BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE VIO 300 D

    MDR report key: 1242532 · Received November 19, 2008

    Report

    Report Number
    9610614-2008-00021
    Event Type
    Other
    Date Received
    November 19, 2008
    Date of Event
    June 17, 2008
    Report Date
    November 19, 2008
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE ESU. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. A REVIEW OF THE INVOLVED PROGRAM [SNARE/HOT BIOPSY PROGRAM (#1), ENDO CUT Q SETTINGS] REVEALED MORE AGGRESSIVE SETTINGS (I.E. EFFECT 2, DURATION 2, AND INTERVAL 3) THAN ARE RECOMMENDED FOR THE MODE. THEREFORE, THE ENDO CUT Q SETTINGS WERE CHANGED TO OUR CURRENT STANDARD DEFAULT SETTINGS (EFFECT 3, DURATION 1, AND INTERVAL 6) TO BETTER MEET THEIR NEEDS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WAS PERFORMED AT THE MEDICAL CENTER IN 2008. NO TRENDS WERE IDENTIFIED WITH THE REPORTED INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED, "COLONOSCOPY WITH POLYPECTOMY DONE WITH ESU AND COLONOSCOPE. A 1 X 1.5 CM POLYP WAS REMOVED IN PIECEMEAL FASHION. PATIENT ADMITTED TO HOSPITAL NEXT DAY WITH SEVERE RLQ PAIN. DIAGNOSED WITH COLON HEMATOMA THAT SUBSEQUENTLY REQUIRED 8 DAYS OF HOSPITALIZATION. REPORTEDLY, SOME GASTROENTEROLOGISTS FELT THE AMOUNT OF VOLTAGE RELEASED WITH THE ENDOCUT WAS TOO HIGH."

    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 NI Hospitalization| R