BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGULATING AND DISSECTING ELECTRODE

    MDR report key: 17118497 · Received June 13, 2023

    Report

    Report Number
    9610617-2023-00882
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Report Date
    June 13, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    KNF
    PMA / PMN Number
    K944862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0074 CORRECTIVE ACTION 6. THE LOCKING CAPS OF THE SUCTION PIPE ARE TORN OFF. THE FRACTURE SURFACES SHOW THE APPEARANCE OF A VIOLENT FRACTURE. THE ARTICLE BROKE DUE TO OVERLOADING. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS EVENT WITH A ELECTRODE. ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE BROKE DURING THE PROCEDURE AS WELL AS THE PLASTIC RING AROUND THE HANDLE. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986747 COAGULATING AND DISSECTING ELECTRODE COAGULATING AND DISSECTING ELECTRODE KNF KARL STORZ SE & CO. KG 37270DL PS01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown