BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 14021084 · Received April 6, 2022

    Report

    Report Number
    9610614-2022-00008
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 6, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE APC/ESU SYSTEM AND FIAPC PROBE WERE THOROUGHLY INSPECTED/TESTED BY ERBE (B)(4). A TECHNICAL SAFETY CHECK WAS PERFORMED ON EACH UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. IN ADDITION, THE GAS FLOW RATES WERE MEASURED AND FOUND TO BE WITHIN THEIR ACCEPTABLE RANGES FOR THE APC. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS ON BOTH DEVICES (NOTE: AN INSPECTION OF THE FIAPC PROBE REVEALED THAT THE DISTAL END HAD BEEN BURNT-OFF). IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) FOR THE APC AND ESU. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. BASED UPON THE REPORTED EVENT, IT APPEARS THAT THE CONCENTRATION OF OXYGEN AT/AROUND THE PROBE'S TIP IN THE AIRWAY WAS AT SUCH A LEVEL THAT UPON ACTIVATION A COMBUSTION/FIRE OCCURRED. THE POTENTIAL OF THIS COMPLICATION IS WELL DOCUMENTED IN PUBLISHED LITERATURE AND IS WIDELY KNOWN IN THE MEDICAL COMMUNITY. ADDITIONALLY, THERE ARE WARNINGS REGARDING THIS TYPE ISSUE IN THE APC 2 USER MANUAL. 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 ERBE SYSTEM, ARGON PLASMA COAGULATOR (APC) WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR, MODEL VIO 300 D, PART NUMBER 10140-100, SERIAL NUMBER (B)(4)) WAS INVOLVED IN A PATIENT INCIDENT. A BRONCHOSCOPY WAS PERFORMED TO ABLATE A FOREIGN BODY (I.E., A SUTURE) IN THE BRONCHUS. A FIAPC PROBE (PART NUMBER 20132-200, LOT NUMBER 163747) WAS USED WITH APC/ESU SYSTEM. WHEN ACTIVATED, A FLAME DEVELOPED AT THE PROBE'S TIP. THEREFORE, THE BRONCHOSCOPE ALONG WITH THE PROBE WERE REMOVED FROM OF THE PATIENT. THEN, A POPPING SOUND WAS HEARD AND A FLAME WAS VISIBLE IN THE BREATHING TUBE. THE PATIENT SUFFERED A BURN TO THE BRONCHIAL TRACT AND LARYNX. TO ADDRESS THE ISSUE, A LONG-TERM INTUBATION AND VENTILATION OF THE PATIENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519263 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention