BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 3

    MDR report key: 14631512 · Received June 8, 2022

    Report

    Report Number
    9610614-2022-00017
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 20, 2022
    Report Date
    June 8, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K191234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    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. SPECIFICALLY, UPON THE INTERVENTION WORK, THE REMAINING TISSUE OF THE BOWL DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATIONS (NOTE: THE TREATMENT WAS NEEDED IN A VERY THIN-WALLED). IN CONCLUSION, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. 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 3, PART NUMBER (P/N) 10160-000, SERIAL NUMBER (B)(4) SYSTEM WAS INVOLVED IN A PATIENT INCIDENT UPON A SPIRAL ENTEROSCOPY WITH ARGON COAGULATION. THE EQUIPMENT WAS USED WITH AN FIAPC PROBE. THE APC/ESU SYSTEM WAS USED TO TREAT ANGIODYSPLASIA IN THE SMALL INTESTINE (MIDDLE ILEUM). THE PATIENT RETURNED HOURS LATER IN PAIN AND UNDERWENT EMERGENCY SURGERY. THREE (3) PERFORATION SITES WERE FOUND. THEREFORE, TO ADDRESS THE ISSUE, A SMALL BOWEL RESECTION (60 CM) WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27261 ERBE APC 3 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 3

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R