BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 10080660 · Received May 21, 2020

    Report

    Report Number
    9610614-2020-00013
    Event Type
    Injury
    Date Received
    May 21, 2020
    Date of Event
    March 13, 2018
    Report Date
    May 21, 2020
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT INCIDENT OCCURRED MORE THAN 2 YEARS AGO AND THE SPECIFIC ERBE ESU USED IN THE PROCEDURE COULD NOT BE IDENTIFIED. THEREFORE, INSPECTION/TESTING OF THE HOSPITAL'S ERBE EQUIPMENT, AT THIS TIME, WOULD NOT BE OF VALUE. NEVERTHELESS, PER A REVIEW OF THE SERVICE RECORDS, NO ISSUES WERE FOUND WITH THE HOSPITAL'S EQUIPMENT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE REPORTED INCIDENT. THEREFORE, NO DEFINITIVE DETERMINATION AS TO WHAT CAUSED THE EVENT COULD BE ASCERTAINED. ERBE USA INC. IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR) AT THE MEDICAL FACILITY. NO SPECIFIC ESU COULD BE IDENTIFIED AS THE INVOLVED EQUIPMENT. THE OTHER SERIAL NUMBERS THAT MAY BEEN INVOLVED WERE (B)(4). AN ESU WAS USED IN AN ESOPHAGOGASTRODUODENOSCOPY (EGD) TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) IN THE DUODENUM. THE GENERATOR WAS USED WITH A BOSTON SCIENTIFIC GOLD PROBE. A PERFORATION OCCURRED AND NO FURTHER INFORMATION INVOLVING THE PATIENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541403 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other