BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 6847759 · Received September 7, 2017

    Report

    Report Number
    9610614-2017-00022
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    April 21, 2017
    Report Date
    September 7, 2017
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 EVENS. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE REPORTED EVENT. IT APPEARS THAT THE COMPLICATIONS WERE A RESULTED PATIENT'S DISEASE STATE (I.E., PUTRIDE CHOLANGITIS WITH INTRA- AND EXTRAHEPATIC CHOLESTASIS AND THUS, POSSIBLY; INFLAMMATORY DUODENAL WALL/LIVER TISSUE/PAPILLARY REGION). THERE WERE NO INDICATIONS IN THE REPORT THAT THE NEUROMUSUCLAR STIMULATION (NMS) CONTRIBUTED TO ANY OF THE PATIENT'S COMPLICATIONS. NEVERTHELESS, NMS CAN OCCUR IN ELECTROSURGERY DUE TO LOW FREQUENCY CURRENTS. IT MAY ALSO BE CAUSED BY EQUIPMENT OR ACCESSORIES NOT BEING INTACT, OR NOT CONNECTIONS NOT BEING SECURE. THERE IS A WARNING IN THE GENERATOR'S USER MANUAL ADDRESSING NMS. NONETHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. NO TRENDS HAVE BEEN IDENTIFIED AND 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 PATIENT INCIDENT. AN EMERGENCY ENDOSCOPIC RETROGRADE CHOLANGIOPANKREATICOGRAPHY (ERCP) AND ENDOSCOPIC PAPILLOTOMY (EPT) WAS PERFORMED ON AN OBESE PATIENT TO EXTRACT STONES. THE SETTINGS OF THE ESU WERE ENDO CUT, EFFECT 1 AND FORCED COAG EFFECT 1, 40 WATTS. THE OTHER EQUIPMENT/ACCESSORIES INVOLVED IN THE PROCEDURE WERE AN OLYMPUS ENDOSCOPE (MODEL TJF-160VR, SERIAL NUMBER (B)(4), A BOSTON SCIENTIFIC HYDRA GUIDEWIRE (JAGWIRE, LOT NUMBER M00556040), ENDO-FLEX DOUBLE LUMEN PAPILLOTOME (PART NUMBER OE1042230DL), AND ERBE NESSY OMEGA RETURN ELECTRODE (PART NUMBER 20193-082). A BALLOON AND BUCKET CATHETER WAS USED IN THE REMOVAL OF THE STONES. DURING THE PROCEDURE THE PATIENT EXPERIENCED NEUROMUSUCLAR STIMULATION (NMS) [NOTE: THE ACCOUNT HAS EXPERIENCED NMS IN OTHER PROCEDURES AND WITH OTHER ESUS PERIODICALLY.]. UPON THE PROCEDURE, THE PATIENT'S HEMOGLOBIN DROPPED AND THERE WAS BLEEDING AND A HEMATOMA IN THE LIVER (RIGHT LOBE). THE SITUATION WAS MOST LIKELY A RESULT OF A LESION IN THE BILE DUCT THAT OCCURRED DURING THE ERCP WITH BLEEDING IN THE LIVER HILUS IN COMBINATION WITH CHOLECYSTITIS. TO IMMEDIATELY ADDRESS THE SITUATION, THE HEMATOMA WAS REMOVED AND THE LIVER WAS WRAPPED. THEN ON (B)(6) 2017, ANOTHER LAPAROSCOPY/CHOLECYSTECTOMY WITH LAVAGE WAS PERFORMED TO RESOLVE THE PATIENT'S ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629997 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R