BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEMOLOK TAKEAPART ML 5MM ENDO APPLIER

    MDR report key: 3072640 · Received April 19, 2013

    Report

    Report Number
    3005236665-2013-00002
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 26, 2013
    Manufacturer
    KMEDIC GMBH, PILLING WECK, TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE HAS NOT BEEN RECEIVED BY MANUFACTURER IN TIME FOR THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: COMPLAINT ALLEGES: THE APPLIER BROKE DURING THE LIGATION OF A CLIP, BUT NOTHING WRONG WAS NOTICED DURING THE INTERVENTION (THE LIGATION HAS BEEN SUCCESSFULLY PERFORMED). DURING THE CLEANING/STORAGE OPERATING ROOM, THE DRESSINGS NURSE NOTICED THAT THE SMALL SCREW (WHICH BRINGS TOGETHER THE JAWS) WAS MISSING, AND WAS NOT RECOVERED. THE DEVICE WAS NOT EXAMINED PRIOR TO USE. AS REPORTED BY THE SURGEONS, NO ACTION WILL BE TAKEN. THERE WAS NO CLINICAL CONSEQUENCE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169244 WECK HEMOLOK TAKEAPART ML 5MM ENDO APPLIER ENDO APPLIER FZP KMEDIC GMBH, PILLING WECK, TELEFLEX MEDICAL 0941690-049

    Patients

    Seq Age Sex Outcome Treatment
    1