BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC ELECTRODE PTFE COATED L WIRE.

    MDR report key: 8023257 · Received October 31, 2018

    Report

    Report Number
    8023257
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    September 29, 2018
    Report Date
    October 26, 2018
    Manufacturer
    XODUS MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC SURGERY, THE L-WIRE WAS ARCHING IN THE ABDOMEN (ELECTRICAL ARCHING), AND IT'S COATING WAS PEELING OFF. ANOTHER L-WIRE HAD TO BE OBTAINED TO COMPLETE THE SURGERY SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866733 LAPAROSCOPIC ELECTRODE PTFE COATED L WIRE. ELECTROSURGICAL, CUTTING COAGULATION GEI XODUS MEDICAL, INC. 18MAR19

    Patients

    Seq Age Sex Outcome Treatment
    1 12775 DA