BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIO 200D

    MDR report key: 5366733 · Received January 14, 2016

    Report

    Report Number
    9610614-2015-00023
    Event Type
    Death
    Date Received
    January 14, 2016
    Date of Event
    November 10, 2015
    Report Date
    January 14, 2016
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. 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 FOR THE DEVICE. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE UNIT'S DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. MOST LIKELY, THERE WERE FACTORS INVOLVED WITH THE PATIENT EVENT (I.E., DISEASE STATE OF THE PATIENT, THE PATIENT'S AGE, ETC.). HOWEVER, A CONCLUSIVE DETERMINATION AS TO THE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. TO FURTHER ADDRESS THE SITUATION, ADDITIONAL CONSULTATION AND TRAINING WAS PERFORMED WITH THE INVOLVED DOCTOR. ALSO, THE DEFAULT FOR THE ENDOCUT I MODE WAS ADJUSTED TO CUT INTERVAL 2, CUT DURATION 3 BY THE ACCOUNT. 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 A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR). THE INCIDENT OCCURRED WHILE PERFORMING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TO REMOVE A STONE. THE SETTINGS WERE ENDOCUT I MODE, EFFECT 3. BLEEDING AND A PERFORATION OCCURRED. THE PATIENT LATER DIED. NOTE: THE ESU IS A SIMILAR UNIT DISTRIBUTED IN THE UNITED STATES. THE GENERATOR WAS DISTRIBUTED BY OUR PARENT COMPANY (B)(4) TO A DISTRIBUTOR IN (B)(4) AND THEN TO AN ENGLISH HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26728 VIO 200D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 200D

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death