BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE VIO 300D

    MDR report key: 5659130 · Received May 17, 2016

    Report

    Report Number
    9610614-2016-00013
    Event Type
    Death
    Date Received
    May 17, 2016
    Date of Event
    October 1, 2015
    Report Date
    May 17, 2016
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU AND BICLAMP INSTRUMENT WAS THOROUGHLY INSPECTED/TESTED BY ERBE ELEKTROMEDIZIN (B)(4) DISTRIBUTOR (B)(4). 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. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) FOR THE GENERATOR. FINALLY, THE BICLAMP INSTRUMENT WAS TESTED AND FOUND TO BE FUNCTIONING PROPERLY. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. BASED UPON THE INFORMATION PROVIDED REGARDING THE EVENT, IT APPEARS THAT THE ISSUE WAS CAUSED BY USER ERROR. THE NOTES ON USE FOR THE INSTRUMENT STATES "DO NOT COAGULATE UNLESS THE JAWS ARE WITHIN YOUR FIELD OF VISION. DO NOT TOUCH ANY METALLIC INSTRUMENTS DURING THIS PROCESS." 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

    IT WAS REPORTED THAT THE ELECTROSURGICAL UNIT (ESU)/GENERATOR WAS USED IN A LAPAROSCOPY WITH AN ERBE BICLAMP LAPAROSCOPIC MARYLAND INSTRUMENT. IT WAS DISCOVERED POSTOPERATIVELY THAT THE PATIENT WAS BLEEDING INTERNALLY. THEREFORE, AN EMERGENCY SURGERY WAS PERFORMED TO ADDRESS THE BLEEDING. THE PATIENT DIED BUT THE CAUSE OF DEATH WAS NOT REPORTED. DURING THE SECOND OPERATION, A CLIP WAS FOUND TO HAVE BEEN DETACHED FROM A BLOOD VESSEL. SUBSEQUENTLY, THE VIDEO OF THE FIRST OPERATION WAS REVIEWED. THE VIDEO OF THE ENDOSCOPIC PROCEDURE REVEALED THAT THE BACK OF THE BICLAMP INSTRUMENT, WHEN ACTIVATED, INADVERTENTLY CAME INTO CONTACT WITH THE INVOLVED CLIP RESULTING IN THE COAGULATION OF THE BLOOD VESSEL. THE PRODUCTS WERE DISTRIBUTED BY ERBE ELEKTROMEDIZIN (B)(4) DISTRIBUTOR (B)(4) TO A (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315031 ERBE VIO 300D ELECTROSURIGCAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300D

    Patients

    Seq Age Sex Outcome Treatment
    1 Death