BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC L-HOOK ELECTRODE

    MDR report key: 7660906 · Received July 3, 2018

    Report

    Report Number
    3007728276-2018-00002
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    January 29, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD
    Product Code
    GEI
    PMA / PMN Number
    K091672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE ELECTROSURGICAL ELECTRODE BEING USED BEGAN TO SPARK WHILE INSIDE THE PATIENT. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE OPERATIVE FIELD AND SEQUESTERED. THE ELECTROSURGICAL SETTINGS WERE 40/40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499941 LAPAROSCOPIC L-HOOK ELECTRODE ELECTROSURGICAL ELECTRODE GEI ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD P0020 1707020

    Patients

    Seq Age Sex Outcome Treatment
    1