BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC

    MDR report key: 18628936 · Received February 2, 2024

    Report

    Report Number
    18628936
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 8, 2024
    Report Date
    January 11, 2024
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS UNDERGOING LAPAROSCOPIC LIVER WEDGE RESECTION AND CHOLECYSTECTOMY. PRIOR TO THE START OF THE PROCEDURE THE TIP OF THE ABC PROBE WAS NOTED TO BE PEELING. A NEW PROBE WAS USED, AND THE AFFECTED PROBE WAS GIVEN TO REPRESENTATIVE, AND SHE BROUGHT IT BACK TO THE COMPANY FOR CREDIT. REF- 160636, LOT- 202310174, EXP. [REDACTED DATE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288159 ABC ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI CONMED CORPORATION 160636 202310174

    Patients

    Seq Age Sex Outcome Treatment
    1 12775 DA Female