BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 1483963 · Received September 23, 2009

    Report

    Report Number
    9610614-2009-00019
    Event Type
    Injury
    Date Received
    September 23, 2009
    Date of Event
    August 25, 2009
    Report Date
    September 23, 2009
    Manufacturer
    ERBE ELECTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU HAS BEEN DEEMED BY THE ACCOUNT TO BE FUNCTIONING AS INTENDED. IT WAS TESTED AT THE HOSPITAL USING ERBE'S OUTPUT MATRIX AND FOUND TO BE WITHIN SPECIFICATIONS. THEREFORE THE GENERATOR WAS PUT BACK INTO SERVICE AND WAS NOT RETURNED TO ERBE FOR AN EVALUATION. ALSO, UPON REVIEWING THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE, THERE WERE NO ANOMALIES. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE COMPLICATION IS NOT A TYPICAL FOR THE PROCEDURE. FURTHERMORE, IT WAS REPORTED THAT THE WRONG FOOTSWITCH PEDAL MAY HAVE BEEN DEPRESSED DURING THE INCIDENT. HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. NO TRENDS WERE IDENTIFIED WITH THE REPORTED SITUATION. NO FURTHER TRAINING WAS CONSIDERED NECESSARY AT THIS TIME BY THE CUSTOMER. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS USED IN A COLONOSCOPY TO REMOVE A LARGE POLYP. THE COLON WALL WAS PERFORATED. SURGICAL INTERVENTION WAS PERFORMED TO ADDRESS THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R