BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE VIO 300 D

    MDR report key: 1901392 · Received November 10, 2010

    Report

    Report Number
    9610614-2010-00023
    Event Type
    Other
    Date Received
    November 10, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. THE UNIT WAS FOUND TO BE FUNCTIONING AS INTENDED. THE EVAL INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. THE GENERATOR WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY (NOTE: AFTER THE EVAL AND UNRELATED TO THE EVENT SOME ROUTINE SERVICE WORK WAS PERFORMED ON THE UNIT.). FINALLY, 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. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADD'L IN-SERVICE WORK WILL BE OFFERED TO BE PERFORMED AT THE MEDICAL CENTER WITH THE INVOLVED STAFF. 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

    IT WAS REPORTED THAT AN ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS USED IN A COLONOSCOPY. THE ESU SETTINGS WERE FORCED COAG MODE, EFFECT 1 AT 15 WATTS. A ONE (1) CM CECAL POLYP WAS REMOVED W/O ANY DIFFICULTY. THE FOLLOWING DAY, THE PT HAD A FEVER, HIGH WBC COUNT, AND ABDOMINAL PAIN. THE PT WAS HOSPITALIZED FOR OBSERVATION WITH POST POLYPECTOMY BURN SYNDROME (NOTE: NO PERFORATION).

    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 83 YR Hospitalization