BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM PEK MONOPOLAR HANDLE 33CM

    MDR report key: 2430698 · Received January 6, 2012

    Report

    Report Number
    2936485-2012-00007
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 9, 2011
    Report Date
    December 9, 2011
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 THE UNIT HAS A BREACH IN THE INSULATION WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM, 33CM PEK MONOPOLAR HANDLE 33CM MONOPOLAR HANDLE GEI STRYKER ENDOSCOPY 0641943D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK