BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOGENT KOAG¿ DISPOSABLE SPETZLER¿ ILLUMINATED BIPOLAR FORCEPS, 8,0.5MM, STRAIGH

    MDR report key: 22094976 · Received May 28, 2025

    Report

    Report Number
    22094976
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 12, 2025
    Report Date
    May 16, 2025
    Manufacturer
    KATALYST SURGICAL,LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PURPLE LIGHT BIPOLAR FORCEPS TIP CAME OFF DURING PROCEDURE. ALL PARTS ACCOUNTED FOR. THE TIP OF THE LIGHTED BIPOLAR BROKE OFF DURING THE PROCEDURE. ALL PIECES WERE ACCOUNTED FOR AND THERE WAS NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR DISPOSABLE ILLUMINATED BIPOLAR FORCEPS, (BRAND NOT PROVIDED) (PER SITE REPORTER). WILL REPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327160 KOGENT KOAG¿ DISPOSABLE SPETZLER¿ ILLUMINATED BIPOLAR FORCEPS, 8,0.5MM, STRAIGH ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI KATALYST SURGICAL,LLC DNL8-05S M44794

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male