BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 8455210 · Received March 27, 2019

    Report

    Report Number
    9610614-2019-00009
    Event Type
    Injury
    Date Received
    March 27, 2019
    Report Date
    March 27, 2019
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. THE UNIT WAS FOUND TO BE FUNCTIONING AS INTENDED. THE EVALUATION 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. A REVIEW OF THE UNIT'S CHRONOLOGICAL LOG REVEALED THAT THE SETTINGS USED WERE AUTOCUT MODE, EFFECT 6, 180 WATTS. 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. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED WITH THE INCIDENT. BASED UPON THE REPORT OF THE PATIENT HAVING A LARGE POLYP WHICH APPEARS TO HAVE BEEN WELL VASCULARIZED, BLEEDING OCCURRED. NEVERTHELESS, THE ACCOUNT WILL BE ADVISED TO USE APPROPRIATE SETTINGS TO ACHIEVE THE DESIRED CLINICAL OUTCOME. IN CONCLUSION, NO DEFINITE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WAS PERFORMED WITH THE INVOLVED MEDICAL STAFF ON 03/18/19. 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 PATIENT INCIDENT DURING/UPON A POLYPECTOMY. AN AMPLIFEYE® ENDOSCOPIC DEVICE BY MEDIVATORS, A NEUTRAL ELECTRODE, AND A MEDIUM SNARE WAS USED IN THE PROCEDURE. THE REPORTED SETTINGS WERE AUTOCUT, EFFECT 6, 70 WATTS. UPON THE REMOVAL OF A LARGE POLYP (30 MM) IN THE DESCENDING COLON WITH A SNARE, BLEEDING OCCURRED. THE PATIENT WAS SURVEILLED FOR A PERFORATION, BUT IT WAS RULED OUT BY A CT SCAN. NO FURTHER INFORMATION WAS PROVIDED IN REGARDS TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248691 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization