BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 5960520 · Received September 19, 2016

    Report

    Report Number
    9610614-2016-00023
    Event Type
    Injury
    Date Received
    September 19, 2016
    Date of Event
    August 8, 2016
    Report Date
    September 19, 2016
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ERBE OFFERED TO EVALUATE THE ESU. THE CUSTOMER RESPONDED "NO NEED TO RETURN UNIT FOR INSPECTION." NONETHELESS, THE GENERATOR'S DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE DHR WAS ACCURATE AND COMPLETE. IN CONCLUSION, NO ISSUES WERE FOUND WITH THE ERBE EQUIPMENT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE REPORTED INCIDENT. IT APPEARS THOUGH THAT THE PATIENT'S CONDITION OF BEING YOUNG (I.E., (B)(6)) WITH A POLYP WAS A SIGNIFICANT FACTOR INVOLVED IN THE EVENT. NEVERTHELESS UPON THE INTERVENTION, THE REMAINING TISSUE OF THE BOWEL WALL DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATION. NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK IS BEING PLANNED WITH THE INVOLVED MEDICAL STAFF ON 10/11/2016. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    A MEDICAL DEVICE REPORT WAS RECEIVED BY ERBE USA, INC. ON 08/26/2016 THROUGH FDA'S MEDWATCH SYSTEM INVOLVING THE ELECTROSURGICAL UNIT (ESU/GENERATOR). IT WAS REPORTED THAT "PATIENT UNDERWENT COLONOSCOPY WITH BIOPSIES AND POLYPECTOMY. NEXT DAY, PATIENT WAS SEEN IN ED FOR ABDOMINAL PAIN AND VOMITING. X-RAY SHOWED FREE AIR AND WAS ADMITTED TO THE HOSPITAL. PATIENT UNDERWENT SURGERY TO REPAIR PERFORATION. PATIENT IS RECOVERING WITHOUT ANY SEQUELAE." ERBE FOLLOWED WITH THE ACCOUNT TO GATHER ADDITIONAL INFORMATION REGARDING THE EVENT. IT WAS REPORTED THAT AN OLYMPUS ENDOSCOPE, MODEL PCF-H190, SERIAL NUMBER (B)(4) AND A COOK ACUSNARE POLYPECTOMY SNARE SOFT SAS-1-S AND CATALOGUE NUMBER G22632 WERE USED IN THE PROCEDURE WITH THE ESU. THE GENERATOR'S SETTINGS WERE ENDOCUT Q, EFFECT 3, CUT DURATION 1, CUT INTERVAL 5 AND FORCED COAG MODE, EFFECT 2, 25 WATTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612808 ERBE VIO 300 D ELECTROSURIGCAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| R