BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 3161570 · Received May 6, 2013

    Report

    Report Number
    9610614-2013-00011
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE PROVIDED INFORMATION, THERE IS NO INDICATION THAT AN EQUIPMENT PROBLEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THE UNIT WAS CHECKED BY THE MEDICAL CENTER'S BIOMEDICAL DIVISION AND NO TROUBLE WAS FOUND. ADDITIONALLY, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED WITH THE PATIENT INCIDENT. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WAS PERFORMED WITH THE HOSPITAL'S ENDOSCOPY STAFF. 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. A COLONOSCOPY WAS BEING PERFORMED TO REMOVE A LARGE POLYP IN THE ASCENDING COLON. THE INITIAL SETTING FOR THE GENERATOR WAS FORCED COAG, EFFECT 1 AT 30 WATTS. HOWEVER, UPON ACTIVATION THERE WERE NO VISIBLE SIGNS OF CAUTERIZATION. CONSEQUENTLY, THE SNARE WIRE WAS LOOSENED AND THEN RE-TIGHTENED AROUND THE POLYP. THE WATTAGE WAS THEN INCREASED FROM 30 TO 32 WATTS. UPON THE POLYPECTOMY, INSUFFLATION WAS LOST DUE TO A PERFORATION. THEREFORE THE PERFORATED AREA WAS RESECTED AND THE TISSUE STAPLED. THE PATIENT WAS STABLE AND DISCHARGED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196724 ERBE VIO 300 D ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R