BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 16551866 · Received March 16, 2023

    Report

    Report Number
    9610614-2023-00016
    Event Type
    Injury
    Date Received
    March 16, 2023
    Date of Event
    March 3, 2023
    Report Date
    March 16, 2023
    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 · 0

    THE ESU AND MONOPOLAR HANDLE WITH CABLE WERE RETURNED AND THOROUGHLY INSPECTED/TESTED. THE FINDINGS WERE AS FOLLOWS: ESU: THE EVALUATION OF THE GENERATOR INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. THE UNIT WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY. ADDITIONALLY, A REVIEW OF THE ESU'S CHRONOLOGICAL DATA AT THE TIME OF THE EVENT DID NOT REVEAL ANY WARNINGS OR ERRORING. FINALLY, NO ANOMALIES WERE FOUND IN THE REVIEW OF THE GENERATOR'S DEVICE HISTORY RECORD (DHR). MONOPOLAR HANDLE WITH CABLE THE ACCESSORIES WERE EXAMINED, BUT NO DEFECTS WERE FOUND. THEN, THE MONOPOLAR HANDLE AND CABLE WERE TESTED. THEY WERE FOUND TO BE FUNCTIONING PROPERLY. IN CONCLUSION, THERE WERE NO ISSUES WITH THE ERBE ESU OR ACCESSORIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. BASED UPON THE PROVIDED INFORMATION, MOST LIKELY THERE WAS INDIRECT OR DIRECT CONTACT BY THE USER (THE INVOLVED THUMB) WITH THE ACTIVE OR HOT INSTRUMENT USED IN THE PROCEDURE. THE INSTRUCTIONS IN THE ESU'S USER MANUAL AND NOTES ON USE OF THE ACCESSORIES WARN OF POSSIBLE BURNS TO USERS FROM SUCH SCENARIOS. 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 SPLENECTOMY. THE ESU WAS USED WITH AN ERBE MONOPOLAR HANDLE [PART NUMBER (P/N) 20190-045, LOT NUMBER (L/N) WO366130 AND AN ERBE MONOPOLAR CABLE (P/N 20192-094, L/N 0821). A SPLIT NEUTRAL ELECTRODE FROM THE 3M COMPANY (P/N 9160F, L/N UNKNOWN) WAS ATTACHED TO THE PATIENT'S RIGHT THIGH. INTRAOPERATIVELY, THE USER'S THUMB WAS BURNT. THE BURN/NECROSIS WAS A 2ND TO 3RD DEGREE BURN OF 0.5 CM2 IN SIZE. THERE WAS NO REPORT OF A PATIENT INJURY. FINALLY, NO INFORMATION WAS CONVEYED TO ERBE INVOLVING ANY MEDICAL TREATMENT PROVIDED TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076807 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Other