BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 13365955 · Received January 27, 2022

    Report

    Report Number
    9610614-2022-00003
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    January 15, 2022
    Report Date
    January 27, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. THE GENERATOR WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY. A REVIEW OF THE UNIT'S CHRONOLOGICAL DATA DIDN'T SHOW ANY ERRORING OR ISSUES WITH THE ESU. ADDITIONALLY, NO ANOMALIES WERE FOUND IN THE REVIEW OF THE GENERATOR'S DEVICE HISTORY RECORD (DHR). IN CONCLUSION, THERE WERE NO ISSUES WITH THE ESU THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. MOST LIKELY, THERE WAS A BREACH IN THE HANDLE OF THE INSTRUMENT WHERE THE SPARKING OCCURRED WHICH CAUSED THE BURN TO THE USER (NOTE: THE NON-ERBE INSTRUMENT AND ACCESSORIES WERE NOT AVAILABLE TO ERBE FOR AN ASSESSMENT.). HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TOI 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 · 0

    IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE ESU WAS USED WITH A STORZ LAPAROSCOPIC INSTRUMENT [PART NUMBER (P/N) 37370 SC AND CABLE (P/N GK 239, SERIAL NUMBER (B)(4)). AN ERBE NESSY OMEGA RETURN ELECTRODE (P/N 20193-082, LOT NUMBER UNKNOWN) WAS ATTACHED TO THE PATIENT'S LEFT THIGH. THE SPRAY COAG MODE WAS BEING USED TO COAGULATE THE LIVER BED. WHEN THE INSTRUMENT WAS ACTIVATED THERE WAS A SPARK ON THE HANDLE OF THE INSTRUMENT WHICH RESULTED IN FOUR (4) SMALL BURNS ON THE USER'S HAND AND FINGERS. EACH WERE 2 MM IN DIAMETER WITH BLISTERS AND BLACK SKIN. TO ADDRESS THE NECROSIS, A WOULD TREATMENT WAS APPLIED TO THE AFFECTED AREA OF THE USER. THERE WERE NO OTHER INJURIES TO THE OPERATOR OF THE DEVICE AND THE PATIENT WAS UNINJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258995 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Required Intervention