BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-HOOK CAUTERY PROBE

    MDR report key: 7372906 · Received March 26, 2018

    Report

    Report Number
    MW5076107
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    March 16, 2018
    Report Date
    March 21, 2018
    Manufacturer
    MICROLINE SURGICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE L-HOOK BROKE OFF A DISPOSABLE L-HOOK CAUTERY DEVICE. THE PIECE WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215304 L-HOOK CAUTERY PROBE ELECTROSURGICAL CUTTING AND COAGULATION GEI MICROLINE SURGICAL 00811099012153 00138577

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention