BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APCAPPLICATOR, WITH FILTER, SHAFT 35MM, RIGID, SPATULA

    MDR report key: 23367613 · Received October 23, 2025

    Report

    Report Number
    9610614-2025-00066
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 23, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K183445
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE APCAPPLICATOR WAS THOROUGHLY INSPECTED AND TESTED (NOTE: THE ERBE APC 3 CONTINUES TO BE USED BY THE CUSTOMER; THEREFORE, THE UNIT WAS NOT AVAILABLE FOR AN EXAMINATION). THE APCAPPLICATOR WAS FOUND TO BE FUNCTIONING AS INTENDED AND NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED. THE EVALUATION INCLUDED A VISUAL INSPECTION AND AN ELECTRICAL FUNCTION CHECK OF EACH OF THE APCAPPLICATOR'S BUTTON FEATURES. THE APCAPPLICATOR WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY. THE SERIAL NUMBER OF THE APCAPPLICATOR WAS NOT PROVIDED, THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED. IN CONCLUSION, NO PROBLEMS WERE FOUND WITH THE APCAPPLICATOR THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. BASED ON THE RESULTS OF THE EVALUATION OF THE APCAPPLICATOR, THE ERROR PATTERN (CONTINUED UNINTENDED ACTIVATION) WAS UNABLE TO BE REPRODUCED. THEREFORE, IT REMAINS UNCLEAR HOW THE UNWANTED ACTIVATION OCCURRED OR WHAT CAUSED THE PATIENT BURN. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN APCAPPLICATOR WAS INVOLVED IN A PATIENT INCIDENT DURING A VALVE REPLACEMENT PROCEDURE. THE APCAPPLICATOR WAS USED WITH AN ERBE ARGON PLASMA COAGULATION MODEL APC 3 (APC/UNIT) (PART NUMBER 10135-000 AND SERIAL NUMBER INFORMATION NOT PROVIDED). NO INFORMATION WAS PROVIDED REGARDING THE APC'S SETTINGS, OR ANY OTHER ACCESSORY USED DURING THE OPERATION. THE USER CONVEYED TO ERBE THAT THE APCAPPLICATOR CONTINUED TO ACTIVATE THE APC AFTER THE COAGULATION BUTTON WAS RELEASED. AT THE END OF THE PROCEDURE, A BURN WAS OBSERVED ON THE PATIENT'S COLLARBONE. NO DESCRIPTION OF THE LESION (BURN) WAS PROVIDED, HOWEVER PER THE REPORT, TREATMENT WAS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505987 APCAPPLICATOR, WITH FILTER, SHAFT 35MM, RIGID, SPATULA RIGID ARGON PLASMA COAGULATION APPLICATORS GEI ERBE ELEKTROMEDIZIN GMBH APCAPPLICATOR SPATULA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Other