BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST BICOAG

    MDR report key: 6507464 · Received April 18, 2017

    Report

    Report Number
    MW5069208
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    April 17, 2017
    Report Date
    April 18, 2017
    Manufacturer
    GYRUS ACMI
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GYRUS ACMI EVEREST BICOAG MACRO JAW FORCEPS NOT CLOSING CORRECTLY X 2 DEVICES. REMOVED FROM SURGICAL FIELD AND REPLACED. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. IS THE PRODUCT COMPOUNDED: #1 NO. #2 NO. IS THE PRODUCT OVER THE COUNTER: #1 NO. #2 NO. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: #1 NO. #2 NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280992 EVEREST BICOAG MACRO JAW FORCEPS GEI GYRUS ACMI 3600 PW303413
    280993 EVEREST BICOAG MACRO JAW FORCEPS GEI GYRUS ACMI PW303542

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR