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Showing 3121–3140 of 11714 results

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8MM Tenaculum Forceps (Intuitive Surgical) – Pitch Cable Failure (2024)

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

FDADec 19, 2024Nationwide• Intuitive Surgical, Inc.

8MM Cadiere Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Maryland Bipolar Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

VITROS 5600 Integrated System (Ortho-Clinical) – Reagent Pack Notification Failure (2024)

The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

FDADec 19, 2024Nationwide• Ortho-Clinical Diagnostics, INc.

KARL STORZ Cysto-Urethroscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

8MM Large Needle Driver (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Small Graptor (Intuitive Surgical) – Pitch Cable Failure (2024)

Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments

FDADec 19, 2024Nationwide• Intuitive Surgical, Inc.

8MM Tenaculum Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Fenestrated Bipolar Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

CryoSolutions Cartridges (New Medical Technologies) – Valve Premature Opening (2024)

During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.

FDADec 19, 2024Nationwide• New Medical Technologies Gmbh Wankdorffeldstrasse

8MM Cobra Grasper (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

VITROS 3600 Immunodiagnostic System (Ortho-Clinical) – Software Notification Failure (2024)

The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

FDADec 19, 2024Nationwide• Ortho-Clinical Diagnostics, INc.

BD PCR Cartridges (Becton Dickinson) – Signal Drift Risk (2024)

Potential for signal drift in specific lots of BD PCR Cartridges.

FDADec 19, 2024Nationwide• Becton Dickinson & Co.

8MM Medium-Large Clip Applier (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

8MM ProGrasp Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Dual Blade Retractor (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM DeBakey Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Mega SutureCut Needle Driver (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

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