BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 2833815 · Received November 7, 2012

    Report

    Report Number
    2027111-2012-00343
    Date Received
    November 7, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 7, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP CHOLE: "4TH OR 5TH CLIP DISLODGE AND DIDN'T CLOSE, SEEM TO FALLOUT OF JAW. DOCTOR THOUGHT THERE MIGHT HAVE BEEN A CHANCE HE CLIPPED ACROSS ANOTHER CLIP ON DUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1169509

    Patients

    Seq Age Sex Outcome Treatment
    1