BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-HOOK CAUTERY

    MDR report key: 3193449 · Received June 21, 2013

    Report

    Report Number
    MW5030665
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    SOLOS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    J-HOOK LAPAROSCOPIC CAUTERY/COAGULATION DEVICE PLACED IN PT'S ABDOMEN THROUGH TROCAR. IT WAS NOTED THAT THE "J" PART OF THE INSTRUMENT WAS BROKEN, BUT STILL INTACT. THE J-HOOK WAS REMOVED INTACT FROM THE PT'S ABDOMEN. AFTER REMOVAL, THE "J" PART OF THE INSTRUMENT CAME APART. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283253 J-HOOK CAUTERY NONE GEI SOLOS GS-5200

    Patients

    Seq Age Sex Outcome Treatment
    1