BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 15995081 · Received December 16, 2022

    Report

    Report Number
    9610614-2022-00048
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 18, 2022
    Report Date
    December 16, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVOLVED EQUIPMENT IS TO BE RETURNED TO ERBE FOR AN EVALUATION (I.E., INSPECTION/TESTING). NO ANOMALIES WERE FOUND IN THE REVIEW OF THE ESU'S DEVICE HISTORY RECORD (DHR). IF THE GENERATOR IS EVALUATED AND PROBLEMS ARE FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT, A FOLLOW-UP REPORT WILL BE FILED. AT THIS TIME, NO CONCLUSIVE DETERMINATION CAN BE MADE AS TO THE CAUSE OF THE EVENT. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). NO INFORMATION WAS PROVIDED IN REGARDS TO THE ACCESSORIES BEING USED. THE ESU SETTINGS WERE ENDOCUT I, EFFECT 2 CUT DURATION 3, CUT INTERVAL 3. A "ZIPPER CUT" (LARGE CUT WITH CHARRING) OCCURRED WHICH RESULTED IN A PERFORATION. TO ADDRESS THE ISSUE, A LAPAROTOMY WAS PERFORMED TO REPAIR THE DUODENAL PERFORATION. THEN, THE PATIENT WAS DISCHARGED AND DOING WELL (NOTE: A WEEK LATER, A DIFFERENT DOCTOR REPORTED THAT THERE WAS NO ENDOCUT TONE WITH A LARGE CUT AND CHARRING. BUT, NO PATIENT INJURY WAS REPORTED.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258346 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention