BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE VIO 200 D

    MDR report key: 18435045 · Received January 3, 2024

    Report

    Report Number
    9610614-2024-00001
    Event Type
    Death
    Date Received
    January 3, 2024
    Date of Event
    November 20, 2023
    Report Date
    January 3, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K080715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR THE DEVICE. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WERE NO REPORTED EQUIPMENT OR ACCESSORY ISSUES. MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE INCIDENT. THEREFORE, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH AMPULLECTOMY. THE ESU WAS USED WITH SNARES (CAPTIVATOR SNARE) FROM BOSTON SCIENTIFIC. THE OTHER ACCESSORIES FROM ERBE WERE A FOOTSWITCH [PART NUMBER (P/N): 20189-302, LOT NUMBER: (L/N) WO266427], MONOPOLAR CABLE /A-CORD [P/N: 20192-117, L/N: INFORMATION NOT PROVIDED (NI)] AND A NEUTRAL ELECTRODE CABLE (P/N: 20194-080, L/N: NI). A NEUTRAL ELECTRODE FROM SKINTACT WAS ATTACHED TO THE PATIENT'S RIGHT THIGH. ACCORDING TO THE USER, THE SETTINGS ON THE ESU WERE SPHINCTEROTOMY: CUT EFFECT 2, FORCED COAG EFFECT 1, 20 WATTS [MAXIMUM (MAX.], RIGHT COLON: CUT EFFECT 1, FORCED COAG EFFECT 1, 15 WATTS (MAX.), LEFT COLON: CUT EFFECT 3, FORCED COAG EFFECT 1, 30 WATTS (MAX.). DURING THE PROCEDURE, A THERMAL INJURY/PERFORATION OCCURRED AROUND THE AREA OF THE AMPULLECTOMY. A CT SCAN SHOWED RETROPERITONEAL GAS ACCUMULATION (I.E., A PERFORATION). TO ADDRESS THE PERFORATION A SECOND OPERATION WAS PERFORMED. HOWEVER, ON (B)(6) 2023; THE PATIENT DIED. NO INFORMATION WAS PROVIDED AS TO THE CAUSE OF THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507606 ERBE VIO 200 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 200 D

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Death| H| R