BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 10183439 · Received June 23, 2020

    Report

    Report Number
    9610614-2020-00018
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 23, 2020
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN THE EQUIPMENT TO ERBE FOR AN EVALUATION BECAUSE THEY DID NOT SEE THAT IT WAS NEEDED. NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) OF THE INVOLVED DEVICES. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE REPORTED INCIDENT. HOWEVER, THE PATIENT'S CONDITION IN ALL LIKELIHOOD WAS A KEY FACTOR IN THE OUTCOME. THAT IS, HAVING AVMS IN THE ASCENDING COLON, A THIN-WALLED AREA OF THE BOWEL. SPECIFICALLY, UPON THE INTERVENTION, THE REMAINING TISSUE OF THE BOWL DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATION. IN CONCLUSION, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WAS OFFERED TO THE MEDICAL STAFF AT THE HOSPITAL. IT IS PENDING PER THE NURSE MANAGER GATHERING ALL INFORMATION PRIOR TO PLANNING ANOTHER IN-SERVICE /CASE SUPPORT WORK. 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) 10140-100, SERIAL NUMBER (B)(4)) WAS INVOLVED IN A PATIENT INCIDENT. THE APC/ESU SETTINGS WERE PULSED APC, EFFECT 2, 30 WATTS WITH A GAS FLOW OF 0.8 LITERS PER MINUTE. THE SYSTEM WAS USED WITH AN FIAPC CIRCUMFERENTIAL PROBE (PART NUMBER 20132-218, LOT NUMBER 141117) TO TREAT ARTERIOVENOUS MALFORMATIONS (AVMS) IN THE ASCENDING COLON. A MICRO PERFORATION OCCURRED; THEREFORE, A LAPAROSCOPY WAS PERFORMED TO CLOSE THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650261 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R