BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 200 S

    MDR report key: 2705726 · Received August 14, 2012

    Report

    Report Number
    9610614-2012-00010
    Event Type
    Injury
    Date Received
    August 14, 2012
    Date of Event
    July 20, 2012
    Report Date
    August 14, 2012
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K080715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS RETURNED AND THOROUGHLY EVALUATED. THE GENERATOR WAS FOUND TO BE FUNCTIONING AS INTENDED. SPECIFICALLY, A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTLET CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS ON THE ESU (NOTE: UNRELATED SERVICE WORK WAS PERFORMED ON THE UNIT.). IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE REPORTED EVENT. HOWEVER, IT APPEARS THAT UPON THE INTERVENTION, THE REMAINING TISSUE OF THE BOWEL WALL AT OR NEAR THE CECUM (A VERY THIN WALLED AREA) DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATION. NONETHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WAS PERFORMED WITH THE STAFF AT THE MEDICAL CENTER. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PT INCIDENT. A PARTIAL CECALECTOMY WAS PERFORMED. THE SETTINGS FOR THE GENERATOR WERE FORCED OR SOFT COAG MODE AT 60 WATTS (NOTE: THE UNIT WAS LOANER EQUIPMENT AND THE STAFF MISTAKENLY USED THE SETTINGS OF THEIR PREVIOUS OLDER MODEL ESU.). THE PT WAS READMITTED THE NEXT DAY WITH REPORTED FREE-AIR. A PERFORATION OCCURRED AT OR NEAR THE CECUM. SURGICAL INTERVENTION WAS REQUIRED TO ADDRESS THE ISSUE AND THE PT IS NOW FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE VIO 200 S ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH VIO 200 S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention