BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEM-O-LOK

    MDR report key: 3588765 · Received December 24, 2013

    Report

    Report Number
    3588765
    Event Type
    Malfunction
    Date Received
    December 24, 2013
    Date of Event
    August 15, 2013
    Report Date
    December 24, 2013
    Manufacturer
    TELEFEX MEDICAL
    Product Code
    HBQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOWRIST CLIP APPLIERS WITH WECK HEM-O-LOK CLIPS WAS BEING USED WHEN THE CLIPS WOULD CLOSE BUT NOT LOCK. MULTIPLE ATTEMPTS WERE MADE WITH DIFFERENT CLIPS FROM DIFFERENT PACKS. A TOTAL OF 5 PACKS AND DIFFERENT APPLIERS WERE USED TO RULE OUT CALIBRATION ISSUES. NO BLOOD LOSS WAS NOTED AND NO INCISION WAS MADE UNTIL THE CLIPS WORKED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674403 WECK HEM-O-LOK LIGATING CLIP HBQ TELEFEX MEDICAL * 01B1300444
    674404 ENDOWRIST SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY TELEFEX MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR DURING ROBOTIC ASSISTED LAPAROSCOPIC RADICAL| PROSTATECTOMY