BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF CONNECTION CABLE MONO L 3M

    MDR report key: 17828134 · Received September 27, 2023

    Report

    Report Number
    9611102-2023-00056
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    June 16, 2023
    Report Date
    September 27, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEI
    UDI-DI
    04055207000694
    PMA / PMN Number
    K982677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING AN HF CONNECTION CABLE MONO L 3M, PART ID: 8106.033, BATCH # 747/675. ACCORDING TO THE RECEIVED INFORMATION, DURING A SCHEDULED LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, A RN CIRCULATOR WAS ATTEMPTING TO PLUG IN BOVIE CORD WHEN A SPARK FROM THE CORD OCCURRED. CORD INSPECTION REVEALED AN INSULATION FRAY WHERE THE SPARK HAPPENED. THERE WAS A REPORTED 5-10 MINUTES DELAY IN THE PROCEDURE. HOWEVER, CORD WAS REMOVED AND REPLACED WITHOUT FURTHER INCIDENT. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019350 HF CONNECTION CABLE MONO L 3M GEI RICHARD WOLF GMBH 8106033 747/675 04055207000694

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female