BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 13666538 · Received March 4, 2022

    Report

    Report Number
    9610614-2022-00006
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    February 2, 2022
    Report Date
    March 4, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL 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. IN ADDITION, NO ANOMALIES WERE FOUND IN DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. BASED UPON THE FINDINGS, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE REPORTED INCIDENT. HOWEVER, THE POLYP BEING LARGE WAS A KEY CIRCUMSTANCE IN THE OUTCOME OF THE EVENT. HOWEVER, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A COLONOSCOPY. A DESCRIPTION OF THE ACCESSORIES USED IN THE PROCEDURE WAS NOT PROVIDED. NOR WERE THE SETTINGS PROVIDED EXCEPT THAT THE ENDOCUT MODE WAS NOT USED. THE UNIT WAS BEING USED TO PERFORM A POLYPECTOMY. THE POLYP WAS VERY LARGE AND COAGULATION WAS BEING USED TO ABLATE THE POLYP. DURING THE PROCESS, AN ESCHAR (I.E., DRY DEAD TISSUE) WAS OBSERVED. THEREFORE, A CT SCAN WAS PERFORMED AND A SMALL PERFORATION WAS FOUND AT THE TREATMENT SITE. A CONTROL ENDOSCOPY SHOWED A SMALL CHARRING; THEREFORE, NO FURTHER THERAPY WAS DEEMED NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177727 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Hospitalization