BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 2

    MDR report key: 14644249 · Received June 9, 2022

    Report

    Report Number
    9610614-2022-00018
    Event Type
    Death
    Date Received
    June 9, 2022
    Report Date
    June 14, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED ERBE EQUIPMENT IS BEING SENT FOR AN EVALUATION. UPON COMPLETION OF THE INSPECTION/TESTING, A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    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. 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, BUT NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICING WAS PERFORMED WITH INVOLVED PERSONNEL AT THE FACILITY. NO TRENDS HAVE BEEN IDENTIFIED. 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)/ELECTROSURGICAL UNIT (ESU/GENERATOR, MODEL VIO 200 S, PART NUMBER (P/N) 10140-400, SERIAL NUMBER (B)(4)) SYSTEM WAS INVOLVED IN A PATIENT INCIDENT DURING/UPON A COLONOSCOPY. THE EQUIPMENT WAS USED WITH AN FIAPC PROBE TO TREAT ARTERIOVENOUS MALFORMATIONS (AVMS) IN THE CECUM (A VERY THIN-WALLED AREA). THE SETTINGS WERE FORCED APC, 25 WATTS, FLOWRATE 0.8 LITERS PER MINUTE. UPON THE TREATMENT, A RIGHT HEMICOLECTOMY WAS NECESSARY. SINCE THE INTERVENTION WORK, THE PATIENT HAS SINCE EXPIRED. THERE WAS NO INFORMATION PROVIDED THAT INDICATED THAT THE PATIENT'S DEATH WAS RELATED TO ANY OF THE GASTROINTESTINAL PROCEDURES. A SECOND PATIENT EVENT WAS MENTIONED, BUT NO DETAILS WERE GIVEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ERBE SYSTEM, ARGON PLASMA COAGULATOR (APC)/ELECTROSURGICAL UNIT (ESU/GENERATOR, MODEL VIO 200 S, PART NUMBER (P/N) 10140-400, SERIAL NUMBER (B)(6)) SYSTEM WAS INVOLVED IN A PATIENT INCIDENT DURING/UPON A COLONOSCOPY. THE EQUIPMENT WAS USED WITH AN FIAPC PROBE TO TREAT ARTERIOVENOUS MALFORMATIONS (AVMS) IN THE CECUM (A VERY THIN-WALLED AREA). THE SETTINGS WERE FORCED APC, 25 WATTS, FLOWRATE 0.8 LITERS PER MINUTE. UPON THE TREATMENT, A RIGHT HEMICOLECTOMY WAS NECESSARY. SINCE THE INTERVENTION WORK, THE PATIENT HAS SINCE EXPIRED. THERE WAS NO INFORMATION PROVIDED THAT INDICATED THAT THE PATIENT'S DEATH WAS RELATED TO ANY OF THE GASTROINTESTINAL PROCEDURES. A SECOND PATIENT EVENT WAS MENTIONED, BUT NO DETAILS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054891 ERBE APC 2 ARGON PLASMA COAGULATION GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Death