BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK TAKEAPART ML 5MM ENDO APPLIER

    MDR report key: 3972840 · Received April 28, 2014

    Report

    Report Number
    3005236665-2014-00006
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    TELEFLEX MEDICAL KMEDIC GMBH
    Product Code
    GDO
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    REPORTED EVENT DESCRIBED AS: ALLEGED ISSUE: IT WAS REPORTED THAT "THE APPLIER BREAKS IN THE JAWS DURING LAPAROSCOPIC SURGERY. IT IS THE FIRST TIME THE APPLIER IS USED. THE SURGEON MANAGED TO GET THE APPLIER OUT OF THE LAPAROSCOPIC PORT. THEY TRY TO LOCATE IF ANY SMALL PIECES ARE LEFT IN THE PT, BUT THEY CAN'T FIND ANY." NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253611 HEMOLOK TAKEAPART ML 5MM ENDO APPLIER TAKEAPART APPLIER GDO TELEFLEX MEDICAL KMEDIC GMBH 544965T P1346004

    Patients

    Seq Age Sex Outcome Treatment
    1