BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPE, GENERAL PLASTIC SURGERY

    MDR report key: 10127880 · Received June 8, 2020

    Report

    Report Number
    10127880
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    May 25, 2020
    Report Date
    June 1, 2020
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY, DOCTOR WAS USING THE LAPAROSCOPIC HOOK TO DISSECT. WHILE DISSECTING, THE HOOK BROKE OFF INSIDE OF THE PATIENT. THE BROKEN PIECE WAS RETRIEVED WITH ALL PIECES ACCOUNTED FOR. LAPAROSCOPIC HOOK SPD STICKER READS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594588 LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ

    Patients

    Seq Age Sex Outcome Treatment
    1