BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 1040155 · Received May 9, 2008

    Report

    Report Number
    9610614-2008-00007
    Event Type
    Injury
    Date Received
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION 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 (NOTE: UNRELATED TO THE REPORTED ISSUE, THE ESU WAS UPDATED TO THE LAST SOFTWARE VERSION UPON BEING CHECKED.). IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVIC HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ALTHOUGH UNCOMMON, THE COMPLICATION IS TYPICAL IN ELECTROSURGERY. MOST LIKELY THERE WERE MANY FACTORS INVOLVED WITH THE SITUATION, AND NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. THE CUSTOMER IS BEING NOTIFIED OF OUR FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WAS PERFORMED WITH INVOLVED PERSONNEL AT THE CUSTOMER SITE IN 2008. 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

    THE ACCOUNT REPORTED THAT THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PT INCIDENT IN THAT A PERFORATION OCCURRED. THE FACILITY WOULD NOT PROVIDE ANY FURTHER INFO REGARDING THE INCIDENT BECAUSE THEY DO NOT BELIEVE THAT THE ESU WAS AT FAULT (NOTE: THEIR BIOMEDICAL DEPT CHECKED THE GENERATOR AND FOUND THE OUTPUTS TO BE WITHIN SPECIFICATIONS.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE VIO 300 D ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI