BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE VIO 300 D

    MDR report key: 4279862 · Received November 19, 2014

    Report

    Report Number
    9610614-2014-00015
    Event Type
    Other
    Date Received
    November 19, 2014
    Date of Event
    October 17, 2014
    Report Date
    November 18, 2014
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IDENTIFIED THE CAUSE OF THE ISSUE TO BE USER ERROR. THEREFORE, THE UNIT IS NOT BEING RETURNED TO ERBE FOR AN EVAL. NO OTHER ISSUES HAVE BEEN REPORTED SINCE THE NOTIFICATION OF THE INCIDENT. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO EQUIPMENT OCCURRED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. TO FURTHER ADDRESS THE ISSUE, ADD'L IN-SERVICE WORK WAS BEING PLANNED WITH THE INVOLVED STAFF AT THE MEDICAL CENTER. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. NO TRENDS HAVE BEEN IDENTIFIED AND 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. DURING A COLONOSCOPY, A POLYPECTOMY WAS PERFORMED. THE STAFF INCORRECTLY SET THE ESU TO THE BASIC PROGRAM AND THE DOCTOR ACTIVATED THE UNIT VIA THE BLUE COAG FOOTPEDAL. THE SETTING USED WAS FORCED COAG, 80M WATTS, EFFECT 2. A LOUD SOUND WAS HEARD AND THERE WAS A BIG SPARK FROM THE SNARE. THE PT'S COLON WAS PERFORATED. THE PERFORATION WAS VERY SMALL AND NO FURTHER INTERVENTION WORK WAS REQUIRED. THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750475 ERBE VIO 300 D ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other