BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 2842467 · Received November 14, 2012

    Report

    Report Number
    2027111-2012-00354
    Event Type
    Other
    Date Received
    November 14, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 14, 2012
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. 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 TO THE FDA.

    Description of Event or Problem · 1

    LAP CHOLE ¿ ¿SURGEON INSERTED THE CLIP APPLIER THROUGH THE 5MM TROCAR. IT DID NOT GO THROUGH THE TROCAR SMOOTHLY. THE SURGEON WENT TO LOAD THE CLIP AND THE BLACK JAW BECAME DISLODGED FROM THE CLIP APPLIER SHAFT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL RESOURCES CORP. CA500 1167850

    Patients

    Seq Age Sex Outcome Treatment
    1