BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR HIGH FREQUENCY CORD, 400 CM

    MDR report key: 23663090 · Received November 26, 2025

    Report

    Report Number
    2020550-2025-02197
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 26, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GEI
    UDI-DI
    04048551388778
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION/INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. ALSO, CORRECTION MADE ON THE REPORT NUMBER TO 2020550-2025-02197 (WE ENTERED THE YEAR OF 2023 IN ERROR ON THE INITIAL IMPORTER). THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4). CROSS REFERENCE COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE INFORMATION RECEIVED, DR (B)(6) WAS PERFORMING A CYSTOSCOPY TURP. HE WAS RE-INSERTING THE WORKING ELEMENT INTO THE SHEATH, AND IT SHOCKED HIS HAND. HE WAS NOT INJURED NOR WAS THE PATIENT. IT DELAYED THE CASE FOR 10 MINUTES WHILE THEY SWITCHED OUT THE EQUIPMENT. DOCTOR SWITCHED TO OTHER DEVICE AND COMPLETED THE PROCEDURE WITHOUT INJURY TO PATIENT. CROSS REFERENCE MDR: 9610617-2025-02198.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978709 BIPOLAR HIGH FREQUENCY CORD, 400 CM BIPOLAR HIGH FREQUENCY CORD, 400 CM GEI KARL STORZ SE & CO. KG UH801 NOT PROVIDED 04048551388778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other