BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS RAPTOR GRASPING DEVICE

    MDR report key: 12568850 · Received October 1, 2021

    Report

    Report Number
    MW5104340
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Report Date
    September 29, 2021
    Manufacturer
    US ENDOSCOPY / UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    OCZ
    UDI-DI
    00724995183653
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ALLIGATOR GRASP MALFUNCTIONED WHILE USING IT IN THE PATIENT TRYING TO GRASP THE STENT [INVALID] THEY WERE UNABLE TO CONTINUE TO USE THE DEVICE OR PULL THE STENT OUT. THEY NEEDED TO CUT THE WIRE AND LEAVE THE DEVICE ATTACHED TO THE STENT AND DEPLOY ANOTHER GRASPER TO GRAB THE STENT AND THE GRASPER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463398 STERIS RAPTOR GRASPING DEVICE ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED OCZ US ENDOSCOPY / UNITED STATES ENDOSCOPY GROUP, INC. 00711177 2108246 00724995183653

    Patients

    Seq Age Sex Outcome Treatment
    1