BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR ELECTRODE

    MDR report key: 17381439 · Received July 24, 2023

    Report

    Report Number
    9610617-2023-00178
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    September 3, 2020
    Report Date
    July 24, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FAS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUS REPORTABILITY DECISION FOR THIS EVENT WAS REVERSED BASED ON A RETROSPECTIVE REVIEW. THIS EVENT WAS RE-OPENED AFTER BEING CAREFULLY IDENTIFIED AS REPORTABLE. PMI IS NOT REQUIRED DUE TO KST REVIEWING AND SIGNING THE DQ. MDR WAS SUBMITTED TO THE FDA AND COPY IS ATTACHED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON WAS PREFORMING A TURB (TRANSURETHRAL RESECTION OF THE BLADDER) AND THE BIPOLAR LOOP BROKE AWAY FROM THE ELECTRODE BODY DURING CUTTING. THE BROKEN PIECE WAS RETRIEVED AFTER THE PROCEDURE AND THE PATIENT WAS NOT INJURED. CUTTING WAS ON EFFECT 2 AND COAGULATION WAS ON EFFECT 4. KARL STORZ AUTOCON GENERATOR AND KARL STORZ BIPOLAR CAUTERY CORD WERE BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423431 BIPOLAR ELECTRODE BIPOLAR ELECTRODE LOOP FAS KARL STORZ SE & CO. KG 011165-10 823150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown