BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 2739236 · Received June 14, 2012

    Report

    Report Number
    2027111-2012-00157
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 14, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE ACKNOWLEDGING RECEIPT OF THE MEDWATCH REPORT. THE CUSTOMER HAS BEEN CONTACTED AND RETURN OF THE DEVICE INCIDENT IS ANTICIPATED. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADD'L INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "DURING PROCEDURE, SURGEON WAS ATTEMPTING TO USE THE EPIX UNIVERSAL 5 MM CLIP APPLIER. THE CLIPS WOULD NOT LOAD PROPERLY. ANOTHER CLIP WAS OPENED AND THESE CLIPS ALSO WOULD NOT LOAD PROPERLY. SURGEON HAD USED THE SAME BRAND OF CLIP APPLIER YESTERDAY WITHOUT ANY PROBLEMS. OTHER STAFF TRIED TO CLIP APPLIER OUTSIDE OF THE PT AND IT MISLOADED FOR BOTH OF THEM. A DIFFERENT BRAND OF 5 MM CLIP APPLIER WAS OPENED AND WAS USED FOR THE PROCEDURE." PT STATUS: OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1164811

    Patients

    Seq Age Sex Outcome Treatment
    1