BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LA8513 - HOOK SUCT COAGULATOR RIGHT ANGLED 33CM

    MDR report key: 5015854 · Received July 27, 2015

    Report

    Report Number
    1423507-2015-00037
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    May 29, 2015
    Report Date
    July 1, 2015
    Manufacturer
    INSTRUMED INTERNATIONAL INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MEDICAL SPECIALITIES - BURN CUSTOMER STATED THAT THE PT WAS BURNED IN THE PLACES NOT INTENDED WHILE PERFORMING LAPAROSCOPIC SURGERY WITH THE ELECTRODES DUE TO METAL BEING EXPOSED ON THE PROXIMAL END OF THE SHAFT. IT IS REPORTED THAT THIS WAS IN USE ON PT WHEN FAILURE OCCURRED AND PT INJURY DID OCCUR. SAMPLE IS AVAILABLE, SENDING CALL TAG TO SALES REP. MFR REPORT # 1421101-2015-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487651 LA8513 - HOOK SUCT COAGULATOR RIGHT ANGLED 33CM ENDOSCOPE AND ACCESSORIES GCJ INSTRUMED INTERNATIONAL INC. LA8513 81241

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other