BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE VIO 300 D

    MDR report key: 1406846 · Received March 24, 2009

    Report

    Report Number
    9610614-2009-00004
    Event Type
    Other
    Date Received
    March 24, 2009
    Date of Event
    March 3, 2009
    Report Date
    March 24, 2009
    Manufacturer
    ERBE ELECTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS RETURNED AND THOROUGHLY EVALUATED. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES AND A POWER OUTPUT CHECK. THE UNIT WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY (NOTE: AFTER THE EVALUATION, SOME UNRELATED SERVICE WORK WAS PERFORMED ON THE UNIT.). IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. A REVIEW OF THE GENERATOR'S CHRONOLOGICAL FILES ON THE DATE OF THE REPORTED INCIDENT REVEAL THAT THE SNARE PROGRAM #10 USED WAS ENDO CUT 1, EFFECT 2, DURATION 2, AND INTERVAL 3. HOWEVER, THE DEFAULT SETTINGS FOR THE PROGRAM SHOULD HAVE BEEN ENDO CUT Q, EFFECT 3, DURATION 1, AND INTERVAL 6. NO DETERMINATION COULD BE MADE AS TO HOW OR WHEN THE PROGRAM WAS CHANGED. NONETHELESS, THE PROGRAM WAS CHANGED BACK TO THE SNARE DEFAULT SETTINGS. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK IS BEING PERFORMED AT THE FACILITY 03/24/09. 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 ELECTRO SURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PATIENT INCIDENT. THE ESU WAS USED IN A COLONOSCOPY FOR A POLYPECTOMY. UPON REMOVING A LARGE POLYP, THE STALK BLED. THE BLEEDING WAS TREATED BY TAMPONADE AND CLIP. HOWEVER, THE PATIENT WAS ADMITTED OVER NIGHT FOR OBSERVATION. THE PATIENT WAS RELEASED THE NEXT DAY.

    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