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Showing 4961–4980 of 22534 results

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Option Elite Retrievable Filter (Argon Medical) – Potential Embolism Risk (2023)

There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.

FDAJun 8, 2023Nationwide• Argon Medical Devices, Inc

EVIS EXERA Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

EVIS EXERA II Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Moderate

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

BD Synapsys Informatics Solution (Becton Dickinson) – Patient Data Mis-association (2023)

There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.

FDAJun 8, 2023CA, CO, IL +12 more• Becton Dickinson & Co.

Bronchofiberscope BF Type (Olympus) – Endobronchial Combustion Risk (2023)

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

HF Resection Electrodes (Olympus) – Wire Breakage Caution (2023)

Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

OES Bronchofiberscope (Olympus) – Endobronchial Combustion Risk (2023)

There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

FDAJun 8, 2023Nationwide• Olympus Corporation of the Americas

FRED Flow Re-Direction Endoluminal Device (MICROVENTION) – Incorrect Inner Stent Length (2023)

Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.

FDAJun 7, 2023Nationwide• MICROVENTION INC.

BeamAdjust Software (PTW-FREIBURG) – Calibration File Error (2023)

Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a DICOM data set is used as reference matrix. Therefore, the measurement result will be incorrect by using such a calibration file.

FDAJun 7, 2023Nationwide• PTW-FREIBURG Lorracher Str. 7 Freiburg Im Breisgau Germany

Vanta AdaptiveStim Neurostimulator (Medtronic) – Cardioversion Damage (2023)

A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.

FDAJun 6, 2023Nationwide• Medtronic Neuromodulation

OmniTom X-ray CT System (NeuroLogica) – Device Mobility Risks (2023)

1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment

FDAJun 6, 2023Nationwide• NeuroLogica Corporation

Vios Bedside Monitor (Murata Vios) – Pulse Oximeter Sensor Failure (2023)

A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.

FDAJun 6, 2023Nationwide• Murata Vios, Inc.

NanoZoomer S360MD Slide Scanner (Hamamatsu) – Incorrect Barcode Identification (2023)

If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient.

FDAJun 6, 2023NY• Hamamatsu Corporation

Giraffe Omnibed Carestation (DATEX-OHMEDA) – Formaldehyde Exposure (2023)

Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.

FDAJun 6, 2023Nationwide• DATEX--OHMEDA, INC.

Catalyft LS Interbody System (Medtronic) – Geometry Specification Issue (2023)

There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

FDAJun 6, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Giraffe Incubator Carestation (DATEX-OHMEDA) – Formaldehyde Exposure (2023)

Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.

FDAJun 6, 2023Nationwide• DATEX--OHMEDA, INC.

Cios Select X-ray System (Siemens) – Plexiglass Cover Issue (2023)

Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g., ingress of a large amount of liquid following the plexiglass dropping off, at the same time the user or operator happens to touch the liquid on the cover which is connected to the internal live parts).

FDAJun 5, 2023Nationwide• Siemens Medical Solutions USA, Inc

Verigene Enteric Pathogens Test (Luminex) – Test Kit Reliability (2023)

It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

FDAJun 5, 2023Nationwide• Luminex Corporation

VITROS Troponin I ES Reagent (ORTHO-CLINICAL) – Incorrect Wells (2023)

Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

FDAJun 5, 2023Nationwide• ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom

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