BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEM-O-LOK AUTO ENDS 5 APPLIER

    MDR report key: 745920 · Received July 14, 2006

    Report

    Report Number
    3003898360-2006-00009
    Event Type
    Other
    Date Received
    July 14, 2006
    Date of Event
    June 1, 2006
    Report Date
    July 13, 2006
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TELEFLEX MEDICAL IS STILL IN THE PROCESS OF EVALUATING THE APPLIER. ONCE IT IS COMPLETED, WE WILL PROVIDE A FOLLOW UP REPORT. THE DHS EVALUATION FOR THIS LOT NUMBER IS ALSO IN PROGRESS AND WILL BE PROVIDED ALONG WITH THE FOLLOW UP.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSPECTOMY PROCEDURE, IT WAS REPORTED THAT PART OF THE APPLIER JAW BROKE OFF INSIDE THE SURGICAL SITE. THE SURGEON WAS ABLE TO RETRIEVE THE JAW WITH MINIMAL TIME, NO PATIENT INJURY OR COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEM-O-LOK AUTO ENDS 5 APPLIER POLYMER LIGATION CLIP APPLIER GDO TELEFLEX MEDICAL NA T1210218

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention