BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ILLUMINATED BIPOLAR FORCEPS, 9INCH, 0.5 MM, STRAIGHT TIPS, STORZ CONN

    MDR report key: 18913356 · Received March 14, 2024

    Report

    Report Number
    MW5152868
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Report Date
    March 12, 2024
    Manufacturer
    KATALYST SURGICAL, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FIBER OPTIC WIRE COMES LOOSE IN THE BACK OF THE DISPOSABLE BIPOLAR AND HAS THE POTENTIAL TO CAUSE A FIRE INTRAOPERATIVELY. SECOND TIME THIS HAS HAPPENED THIS YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185091 DISPOSABLE ILLUMINATED BIPOLAR FORCEPS, 9INCH, 0.5 MM, STRAIGHT TIPS, STORZ CONN ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI KATALYST SURGICAL, LLC M40691

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown