BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 2

    MDR report key: 5555080 · Received April 7, 2016

    Report

    Report Number
    9610614-2016-00008
    Event Type
    Death
    Date Received
    April 7, 2016
    Date of Event
    March 11, 2016
    Report Date
    April 7, 2016
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE APC/ESU SYSTEM WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. THE SYSTEM'S CHRONOLOGICAL LOG WAS REVIEWED. BASED UPON THE LOG, IT APPEARS THAT THE FIRST CASE WAS DONE ON (B)(6) 2016 AND NOT 03/11/2016. NO OTHER NOTABLE INFORMATION WAS DETERMINED FROM THE LOG. 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. ADDITIONALLY, 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 EVENTS. MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE REPORTED EVENTS. HOWEVER IT APPEARS THAT WITH THE FIRST PATIENT, HER VERY POOR HEALTH AND THE TARGET AREA BEING PREVIOUSLY TREATED WERE SIGNIFICANT ASPECTS OF THE INCIDENT. NOTABLE CIRCUMSTANCES IN REGARDS TO THE PROCEDURAL OUTCOME WITH THE SECOND PATIENT INVOLVED THE TARGET TREATMENT AREA BEING THIN AND SHE WAS VERY OLD. IN SUMMARY, DURING THE INTERVENTION WORK ON THE COMPROMISED PATIENTS, THE REMAINING WALL DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATION IN BOTH SUBJECTS. NONETHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENTS. TO FURTHER ADDRESS THE SITUATION, ADDITIONAL IN-SERVICE WORK WITH THE MEDICAL STAFF IS BEING PLANNED. NO TRENDS HAVE BEEN IDENTIFIED WITH THESE INCIDENTS. ERBE USA, INC. IS NOW CLOSING THE FILE ON THESE EVENTS.

    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) [PART NUMBER (P/N) 10140-000, SERIAL NUMBER (S/N) (B)(4)) WAS INVOLVED IN TWO (2) PATIENT INCIDENTS. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED ON THE FIRST PATIENT (REPORTED DATE OF EVENT AND PATIENT INFORMATION DOCUMENTED ABOVE) TO TREAT A LARGE DEEP GASTRIC ULCER. THE APC WITH A STRAIGHTFIRE PROBE WAS USED TO TREAT THE ULCER. THE PROCEDURE APPEARED TO GO WELL; HOWEVER, A PERFORATION RESULTED. THE PATIENT DIED A SHORT TIME LATER. THEN ON (B)(6) 2016, AN EGD WAS PERFORMED ON A SECOND PATIENT. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE. THE APC WITH A SIDEFIRE PROBE WAS USED TO TREAT A DUODENAL ULCER. THE PROCEDURE AGAIN WENT WELL BUT A PERFORATION OCCURRED. NO FURTHER INFORMATION WAS MADE AVAILABLE INVOLVING THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208914 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death