BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERVE VIO 300 D

    MDR report key: 1304568 · Received January 30, 2009

    Report

    Report Number
    9610614-2009-00001
    Event Type
    Injury
    Date Received
    January 30, 2009
    Date of Event
    January 8, 2009
    Report Date
    January 30, 2009
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU AND FOOTSWITCH WERE 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 FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS ON THE ESU. THE FOOTSWITCH WAS ALSO EVALUATED AND FOUND TO BE WORKING AS INTENDED. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT (NOTE: THEN UNRELATED TO THE REPORTED INCIDENT, SOME ROUTINE SERVICE/UPGRADE WORK WAS PERFORMED ON THE GENERATOR). MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE REPORTED EVENT. HOWEVER, IT APPEARS THAT UPON REMOVING A POLYP, THE REMAINING BOWEL WALL WAS NOT SUFFICIENT TO REMAIN INTACT IN THE THIN WALLED AREA OF THE CECUM. 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 WILL BE OFFERED TO THE MEDICAL STAFF AT THE HOSPITAL. 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. THE ESU WAS USED IN A COLOSCOPY FOR A POLYPECTOMY. THE SETTINGS WERE ENDOCUT MODE Q AT EFFECT 3, DURATION 1, AND INTERVAL 4. AFTER THE PROCEDURE, THE PT WENT HOME, BUT LATER RETURNED TO THE EMERGENCY ROOM. A PERFORATION WAS DISCOVERED, AND SURGERY WAS PERFORMED TO ADDRESS THE SITUATION. HOWEVER, THE PT HAD DIFFICULTY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERVE VIO 300 D ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R