BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 200 S

    MDR report key: 1892086 · Received November 2, 2010

    Report

    Report Number
    9610614-2010-00021
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K080715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU HAS BEEN PUT BACK INTO SERVICE; THEREFORE, THE UNIT WAS NOT RETURNED TO ERBE FOR AN EVALUATION. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO EQUIPMENT PROBLEM OCCURRED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE REPORTED EVENT. HOWEVER, IT APPEARS THAT UPON THE INTERVENTION WORK TO REMOVE THE POLYP, THE REMAINING TISSUE OF THE BOWEL WALL DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATION (I.E., THE POLYP WAS IN A VERY THIN WALLED AREA AND THERE WAS NOT ENOUGH WALL REMAINING TO STAY INTACT). NONETHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. NO TRENDS WERE IDENTIFIED WITH THE REPORTED SITUATION AND THE ACCOUNT DOESN'T NEED ANY ADDITIONAL INSERVICING. 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 PATIENT INCIDENT. THE ESU WAS USED TO REMOVE A CECAL POLYP. THE SETTINGS FOR THE GENERATOR WERE FORCED COAG MODE, EFFECT 1, 25 WATTS. THE PATIENT COMPLAINED OF ABDOMINAL PAIN FOLLOWING THE PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL THE NEXT DAY AND SURGICAL INTERVENTION WAS PERFORMED TO ADDRESS A PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE VIO 200 S ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH VIO 200 S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R