BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWO-PEDAL FOOTSWITCH HF GENERATORS

    MDR report key: 21873797 · Received April 21, 2025

    Report

    Report Number
    2020550-2025-00639
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 21, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GEI
    UDI-DI
    04048551372203
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. CROSS REFERENCE INTERNAL COMPLAINT ID (B)(4). THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSUFFICIENT MONOPOLAR CAUTERY. PATIENT INVOLVED. PATIENT WAS INJURED; CUSTOMER HAD TO GET A BLOOD TRANSFUSION. PHYSICIAN WAS ATTEMPTING TO CAUTERIZE WITH THE 5MM ROLLER-BALL MONOPOLAR ELECTRODE AND INSUFFICIENT CAUTERY CAUSED EXCESSIVE BLEEDING. COAGULATION WAS MAXED AT 120 WATTS. PATIENT HAD TO HAVE BLOOD TRANSFUSED. CROSS REFERENCE UF/IMPORTER REPORT # 2020550-2025-00638.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161167 TWO-PEDAL FOOTSWITCH HF GENERATORS TWO-PEDAL FOOTSWITCH HF GENERATORS GEI KARL STORZ SE & CO. KG UF902 04048551372203

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention