BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR CORD FROM THE GU ROBOTIC PACK

    MDR report key: 11147360 · Received January 8, 2021

    Report

    Report Number
    MW5098750
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    December 29, 2020
    Report Date
    January 7, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    NWU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE ATTEMPTED TO PLUG THE BIPOLAR CORD FROM THE GU ROBOTIC PACK INTO THE BOVIE AND ONE PRONG WOULD NOT SEAT APPROPRIATELY NOR STAY IN THE OUTLET. NEW CORD OBTAINED AND IT ATTACHED WITH NO ISSUES. PACK INFO IS AS FOLLOWS: SBA21RUDCD, LOT#493772, EXP.DATE: 2023-03-01, MFG.DATE: 2020-09-01, M# 3617001. NO PATIENT INJURY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34024 BIPOLAR CORD FROM THE GU ROBOTIC PACK ENDOSCOPE INTRODUCER KIT NWU CARDINAL HEALTH 200, LLC 3617001 493772

    Patients

    Seq Age Sex Outcome Treatment
    1