BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 2

    MDR report key: 9841409 · Received March 17, 2020

    Report

    Report Number
    9610614-2020-00005
    Event Type
    Death
    Date Received
    March 17, 2020
    Date of Event
    January 30, 2020
    Report Date
    March 17, 2020
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE APC/ESU SYSTEM WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON EACH UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL 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. A REVIEW OF THE CHRONOLOGICAL DATA ALSO DIDN'T REVEAL ANY EQUIPMENT PROBLEMS DURING THE PROCEDURE OR AT ANY OTHER TIME. 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. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE REPORTED INCIDENT. HOWEVER, THE PATIENT'S CONDITION IN ALL LIKELIHOOD WAS A KEY FACTOR IN THE OUTCOME. THE PATIENT APPEARED TO BE VERY ILL WITH MANY COMPLICATIONS PRIOR TO TREATMENT. IN CONCLUSION, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WAS OFFERED TO THE MEDICAL STAFF AT THE HOSPITAL; HOWEVER, IT WAS DECLINED (NOTE: THE PHYSICIAN AND STAFF DOESN'T BELIEF THAT THE EQUIPMENT MALFUNCTIONED.). NO TRENDS HAVE BEEN IDENTIFIED AND 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) WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR, MODEL VIO 300 D, PART NUMBER 10140-100, SERIAL NUMBER (B)(4)) WAS INVOLVED IN A PATIENT INCIDENT IN WHICH THE PATIENT HAD AN ESOPHAGOGASTRODUODENOSCOPY (EDG) AND A COLONOSCOPY. THE APC/ESU SETTINGS WERE PULSED APC, EFFECT 2, 30 WATTS. THE SYSTEM WAS USED WITH AN APC CIRCUMFERENTIAL PROBE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) IN THE STOMACH. THE PATIENT WAS RELEASED, BUT LATER RETURNED THAT NIGHT. A BLOOD CLOT OR SIMILAR WAS SUSPECTED. THE PATIENT DIED THE NEXT DAY (NOTE: THE HOSPITAL'S RISK MANAGER DID NOT FEEL THAT THE PATIENT'S DEATH IS RELATED; HOWEVER, THEY WANTED THE EQUIPMENT TESTED.). PRIOR TO TREATMENT THE PATIENT HAD BLOOD LOSS, WAS ANEMIA, AND HAD RECTAL BLEEDING. PATIENT WAS ALSO ON A BLOOD THINNER FOR ATRIAL FIBRILLATION (AFIB).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303436 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death