BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 1211592 · Received October 23, 2008

    Report

    Report Number
    9610614-2008-00019
    Event Type
    Injury
    Date Received
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED ESU WAS EVALUATED. THE CHRONOLOGICAL FILE OF THE UNIT'S USE WAS CHECKED AND THERE WAS NO INDICATION OF CONTINUOUS ACTIVATION FROM THE GENERATOR. THE INSPECTION/TESTING ALSO 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 GENERATOR. NO ANOMALIES WERE FOUND IN A DEVICE HISTORY RECORDS (DHR) REVIEW FOR THE UNIT. IN CONCLUSION, THERE WAS NO PROBLEM FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS SITUATION. ERBE USA IS NOW CLOSING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR). DURING A PROCEDURE, THE ACCOUNT SAID THAT THE ESU CONTINUED TO ACTIVATE, RESULTING IN NECROSIS OF TISSUE IN THE BOWEL. THE PATIENT WILL HAVE TO UNDERGO AN ADDITIONAL SURGERY TO ADDRESS THE ISSUE. NOTE: THE GENERATOR WAS DISTRIBUTED BY OUR PARENT COMPANY TO A HOSPITAL IN ANOTHER COUNTRY.

    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 Hospitalization| R