BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 300

    MDR report key: 15624530 · Received October 18, 2022

    Report

    Report Number
    9610614-2022-00037
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    September 14, 2022
    Report Date
    October 18, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K963189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS A PLAN TO HAVE THE ERBE EQUIPMENT CHECKED/EVALUATED AT ERBE USA. IF ANY ISSUES ARE FOUND WITH THE EQUIPMENT THAT MAY BE ASSOCIATED WITH THE EVENT, A FOLLOW UP REPORT WILL BE PROVIDED. NO ANOMALIES WERE FOUND IN DEVICE HISTORY RECORDS (DHRS) OF THE INVOLVED DEVICES. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE EVENT. HOWEVER, THE PATIENT'S CONDITION APPEARS TO HAVE PLAYED A SIGNIFICANT ROLE IN THE INCIDENT. SPECIFICALLY, UPON THE INITIAL INTERVENTION WORK, THE BLEEDING WAS RESOLVED BUT BLEEDING AGAIN OCCURRED WITHIN A WEEK. NEVERTHELESS, AT THIS TIME, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK AT THE ACCOUNT WAS DONE WITH THE INVOLVED STAFF ON 09/30/22. NO TRENDS HAVE BEEN IDENTIFIED AND 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 ICC 200 E/A, PART NUMBER (P/N) 10128-205, SERIAL NUMBER (B)(4) SYSTEM WAS INVOLVED IN A PATIENT INCIDENT UPON A COLONOSCOPY. AN APC CIRCUMFERENTIAL PROBE WAS USED IN THE PROCEDURE. ARGON PLASMA COAGULATION WAS APPLIED TO ADDRESS AN ARTERIOVENOUS MALFORMATION (AVM) IN THE CECUM TO STOP INTESTINAL BLEEDING. THE EQUIPMENT SETTINGS WERE 45 WATTS, 2 LITERS PER MINUTE. UPON ACTIVATION, A SECONDARY MONITOR BLACKED OUT FOR A SECOND PER A NURSE. NEVERTHELESS, PER THE PHYSICIAN, A SATISFACTORY HEMOSTASIS WAS ACHIEVE; THEREFORE, THE PATIENT WAS DISCHARGED FROM THE MEDICAL CENTER. HOWEVER, SIX (6) DAYS LATER HE WAS ADMITTED TO A LOCAL HOSPITAL DUE TO BLEEDING AGAIN AT THE TREATED SITE. THEREFORE, A PARTIAL COLECTOMY WAS PERFORMED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481950 ERBE APC 300 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 300

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| H