BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18676740 · Received February 9, 2024

    Report

    Report Number
    18676740
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    December 13, 2023
    Report Date
    December 15, 2023
    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

    THE TIP OF A KOGENT KOAG¿ DISPOSABLE SPETZLER¿ ILLUMINATED BIPOLAR FORCEPS, 8",0.5MM, STRAIGHT BROKE OFF DURING A RIGHT FRONTAL CRANIOTOMY FOR TUMOR WITH ASLEEP MOTOR MAPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242408 KOGENT KOAG¿ DISPOSABLE SPETZLER¿ ILLUMINATED BIPOLAR FORCEPS, 8,0.5MM, STRAIGH ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI KATALYST SURGICAL LLC DNL8-05S M39679

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male