BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGULATING AND DISSECTING ELECTRODE

    MDR report key: 21882659 · Received April 22, 2025

    Report

    Report Number
    9610617-2025-00658
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    February 15, 2025
    Report Date
    October 15, 2025
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    KNF
    UDI-DI
    04048551155653
    PMA / PMN Number
    K944862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: ANALYSIS OF THE COMPLAINTS REGARDING ITEMS 37370DL (BATCH ZM01) AND 30804 (BATCH NL02) REVEALS THE FOLLOWING KEY POINTS: ITEM 37370DL (ZM01): THE BREAKAGE OF THE HOOK IS MOST LIKELY DUE TO INCORRECT OR INSUFFICIENT REPROCESSING. VISIBLE CORROSION AND CONTAMINATION AT THE BREAK POINT INDICATE THAT THE IFU SPECIFICATIONS AND REPROCESSING INSTRUCTIONS WERE NOT FOLLOWED. THIS PRESUMABLY LED TO THE FORMATION OF MICROCRACKS, WHICH WEAKENED THE MATERIAL STRUCTURE AND ULTIMATELY CONTRIBUTED TO THE BREAKAGE. - ITEM 30804 (NL02): ONLY SIGNS OF WEAR WERE FOUND; THE ITEM IS STILL FUNCTIONAL. THE CUSTOMER'S DESCRIPTION MATCHES THE PREVIOUSLY EXAMINED ITEM 37370DL, SO NO FURTHER INVESTIGATION IS NECESSARY. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE COAGULATOR HOOK BROKE AND FELL INTO THE ABDOMINAL CAVITY. THE FRAGMENT WAS SPOTTED BY ENDOSCOPY AND REMOVED IN ITS ENTIRETY FROM THE ABDOMINAL CAVITY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015516 COAGULATING AND DISSECTING ELECTRODE COAGULATING AND DISSECTING ELECTRODE KNF KARL STORZ SE & CO. KG 37370DL ZM01 04048551155653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 30804 HANDLE WITH TRUMPET VALVE