BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WECK HEM-O-LOCK

    MDR report key: 6380648 · Received March 2, 2017

    Report

    Report Number
    MW5068274
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    February 24, 2017
    Report Date
    March 2, 2017
    Manufacturer
    TELEFLEX
    Product Code
    HBQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING LAPAROSCOPIC CHOLECYSTECTOMY. DURING PROCEDURE, IT WAS NOTED THAT THE DISPOSABLE WECK HEM-O-LOCK DEVICE HAD MALFUNCTIONED. SURGEON FOUND THE TIP TO BE LOOSE AND IT BROKE OFF IN HIS HAND. SECOND HEM-O-LOCK WAS OPENED AND FOUND TO BE DEFECTIVE ALSO - THE CLIP WOULD NOT OPEN FULLY WHEN IT WAS ENGAGED IN THE INSTRUMENT. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153795 WECK HEM-O-LOCK WECK HEM-O-LOCK HBQ TELEFLEX 73A1700205
    153796 WECK HEM-O-LOCK WECK HEM-O-LOCK HBQ TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention