BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 9129376 · Received September 27, 2019

    Report

    Report Number
    9610614-2019-00022
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    August 28, 2019
    Report Date
    September 27, 2019
    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 · 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 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. IN ADDITION, NO ANOMALIES WERE FOUND IN EITHER OF THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICES. IN CONCLUSION, NO EQUIPMENT PROBLEMS OCCURRED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE REPORTED INFORMATION, THE PROBE WAS ACTIVATED WHEN CONTACTING THE BOWEL WALL. THE PROBE'S USE (I.E., TREATING TISSUE WITH ARGON PLASMA) IS A NON-CONTACT MODALITY AND ACTIVATION WHILE CONTACTING THE TISSUE MOST LIKELY CAUSED THE PERFORATION. 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 (P/N) 10140-000, SERIAL NUMBER (B)(4)) WAS INVOLVED IN A PATIENT INCIDENT. A COLONOSCOPY WAS BEING PERFORMED TO REMOVE A POLYP. INITIALLY A FILTER INTERGRATED ARGON PLASMA COAGULATION (FIAPC) PROBE DIDN'T WORK; THEREFORE, ANOTHER PROBE WAS EXCHANGED. HOWEVER, WHEN ACTIVATING THIS PROBE IT WAS STICKING TO THE INTESTINAL WALL (ON THE LEFT SIDE) WHICH CAUSED A PERFORATION. SURGICAL INTERVENTION WAS PERFORMED TO CLOSE THE PERFORATION. NO FURTHER INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924516 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention