BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPTOR TOOL

    MDR report key: 16573824 · Received March 17, 2023

    Report

    Report Number
    MW5115832
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 17, 2023
    Report Date
    March 15, 2023
    Manufacturer
    STERIS /UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    OCZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 4:42 PM BY RISK, RDE - RAPTOR TOOL USED FOR FOREIGN BODY REMOVAL. DEVICE WORKED ON FIRST PASS, BUT DURING THE SECOND PASS GI TECH WAS UNABLE TO OPEN RAPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937878 RAPTOR TOOL ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED OCZ STERIS /UNITED STATES ENDOSCOPY GROUP, INC. 00711177 442392

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female