BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE FILTER INTEGRATED APC (FIAPC®) CIRCUMFERENTIAL PROBE

    MDR report key: 24799954 · Received April 7, 2026

    Report

    Report Number
    9610614-2026-00062
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 7, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIAPC CIRCUMFERENTIAL PROBE WAS EVALUATED BY ERBE USA ON 04/01/2026. THE VISUAL EXAMINATION REVEALED THAT THERE WAS A BEND IN THE BLUE TUBING 1986MM FROM THE DISTAL END. ALSO, THERE WAS A HOLE IN THE BLUE TUBING APPROXIMATELY 1MM IN DIAMETER AND 6.5MM FROM THE DISTAL END. BASED UPON THE DAMAGE TO THE PROBE AND SCOPE, IT APPEARS THAT THERE WAS THERMAL OVERLOAD. HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE DAMAGE TO THE FIAPC CIRCUMFERENTIAL PROBE. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE LOT OF THE FIAPC CIRCUMFERENTIAL PROBE. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH THE FILTER INTEGRATED APC (FIAPC) CIRCUMFERENTIAL PROBE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EDG). THE ACCESSORY WAS USED WITH AN ERBE ARGON PLASMA COAGULATOR (MODEL APC 2, PART NUMBER 10134-000, SERIAL NUMBER (B)(6)/ELECTROSURGICAL UNIT (MODEL VIO 300 D), PART NUMBER 10140-100, SERIAL NUMBER (B)(6) SYSTEM. THE SETTINGS WERE PULSEDAPC MODE, EFFECT 2, 30 WATTS. PER THE REPORT, "THE PROBE STARTED ARCING OUT THE SIDE OF THE CATHETER AND BURNED A HOLE THROUGH THE BLUE PLASTIC, AS WELL AS BURNED AND MELTED THE TIP OF THE SCOPE." THERE WAS NO REPORT OF AN INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863607 ERBE FILTER INTEGRATED APC (FIAPC®) CIRCUMFERENTIAL PROBE ARGON-ENHANCED ENDOSCOPIC ELECTROSURGICAL ELECTRODE GEI ERBE ELEKTROMEDIZIN GMBH 226898

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown