BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM, 33CM RATCHETING HANDLE

    MDR report key: 2946234 · Received January 4, 2013

    Report

    Report Number
    2936485-2013-90001
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BREACH IN INSULATION WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5015 10MM, 33CM RATCHETING HANDLE KOG STRYKER ENDOSCOPY SAN JOSE 0847650D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK