BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTTING LOOP, BIPOLAR, 26 FR.

    MDR report key: 22777207 · Received August 11, 2025

    Report

    Report Number
    2020550-2025-01400
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 11, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    HIN
    UDI-DI
    04048551392720
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE WILL NOT RETURN FOR INVESTIGATION DUE TO THE CUSTOMER DID NOT SAVE THE BROKEN ELECTRODES. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4). CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2025 TWO (2) ELECTRODES BROKE. ACCORDING TO THE DOCTOR, A PIECE WAS RETAINED IN THE PATIENT AND THEY DID NOT SAVE THE BROKEN ELECTRODES. CROSS REFERENCE MEDWATCH NUMBER 2020550-2025-01399.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159788 CUTTING LOOP, BIPOLAR, 26 FR. CUTTING LOOP, BIPOLAR, 26 FR. HIN KARL STORZ SE & CO. KG 26040GP1 04048551392720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other