BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 15904075 · Received December 2, 2022

    Report

    Report Number
    9610614-2022-00045
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    November 14, 2022
    Report Date
    December 2, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. HOWEVER, THE PATIENT BEING ELDERLY, A VERY THIN-WALLED AREA NEEDED TO BE TREATED, ETC. WERE KEY PATIENT FACTORS IN THE EVENT. NEVERTHELESS, UPON INTERVENTIONAL WORK, THE REMAINING TISSUE OF THE BOWL DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATION. FINALLY, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. 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 D, PART NUMBER (P/N) 10140-200, SERIAL NUMBER (B)(4)) SYSTEM WAS INVOLVED IN A PATIENT INCIDENT. THE APC/ESU SYSTEM WAS USED TO ADDRESS ANGIODYSPLASIA IN THE CECUM. AFTER AN ARGON PLASMA APPLICATION, A DELAYED PERFORATION OCCURRED. THEREFORE, AN EMERGENCY LAPAROSCOPY WAS PERFORMED TO SUTURE THE SITE CLOSED. THE PATIENT HAD TO BE HOSPITALIZED FOR SEVEN (7) DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348985 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention| H