BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 6299624 · Received February 3, 2017

    Report

    Report Number
    9610614-2017-00003
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    January 6, 2017
    Report Date
    February 3, 2017
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARGON PLASMA COAGULATOR (APC)/ELECTROSURGICAL UNIT (ESU) SYSTEM WAS RETURNED AND THOROUGHLY EVALUATED. THE FINDINGS WERE AS FOLLOWS: CHRONOLOGICAL LOG REVIEW: THE LOG ON THE DAY OF THE REPORTED EVENT WAS REVIEWED. NO SYSTEM ISSUES WERE RECORDED. APC/ESU INSPECTION AND TESTING: 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. ALSO, 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. 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. NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE SITUATION, ADDITIONAL CASE WORK IS BEING PLANNED WITH THE DOCTOR. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERBE SYSTEM, ARGON PLASMA COAGULATOR (APC) MODEL APC 2 WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR) SYSTEM [PART NUMBER (P/N) 10140-100, SERIAL NUMBER (S/N) (B)(4))] WAS INVOLVED IN A PATIENT INCIDENT. THE EQUIPMENT WAS USED TO REMOVE A POLYP. DEFAULT SETTINGS WERE USED, BUT CAUTERY DID NOT FUNCTION PROPERLY. AFTER THE PROCEDURE, SURGICAL INTERVENTION WORK WAS DONE. NO FURTHER INFORMATION WAS PROVIDED ON THE REASON FOR THE SECOND PROCEDURE OR THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83207 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention