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Vortex MP Port (Angiodynamics) – Missing Instructions (2022)

Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.

Moderate

FDASep 20, 2022Nationwide• Angiodynamics, Inc.

da Vinci X (Intuitive Surgical) – Inadvertent Energy Delivery (2022)

Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery

High

FDA

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Vortex MP Port (Angiodynamics) – Missing Instructions (2022)

da Vinci X (Intuitive Surgical) – Inadvertent Energy Delivery (2022)

Atellica CH Lithium Test (Siemens) – False Results Risk (2022)

Atellica CH Lithium Test (Siemens) – False Results Risk (2022)

iGO2 Oxygen Concentrator (DeVilbiss) – Unapproved Adhesive (2022)

Berkeley VC-10 System (Olympus) – IFU Update (2022)

Prep-Fill Connector (IMI) – Compromised Sterility (2022)

ULTRASITE Extension Set (B. Braun) – Joint Failure Risk (2022)

CARESITE Extension Set (B. Braun) – Joint Failure Risk (2022)

Extension Set (B. Braun) – Joint Failure Risk (2022)

Vacutainer Tube (Becton Dickinson) – Methanol Interference (2022)

Prismaflex HF Set (Baxter) – Translation Error (2022)

Disc Preparation Instruments (Alphatec) – Manufacturing Error (2022)

Prismaflex HF20 Set (Baxter) – Translation Error (2022)

Prismaflex ST Set (Baxter) – Translation Error (2022)

ARIES SARS-CoV-2 Assay (Luminex) – Extraction Defect (2022)

Prismaflex M Set (Baxter) – Translation Error (2022)

Prismaflex M Set (Baxter) – Translation Error (2022)

NovoTHOR Gen 2.0 (Thor) – Gas Strut Detachment (2022)

NovoTHOR Gen 2.5 (Thor) – Gas Strut Detachment (2022)