BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3030446 · Received March 26, 2013

    Report

    Report Number
    2027111-2013-00105
    Date Received
    March 26, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 26, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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.

    Description of Event or Problem · 1

    LAPAROSCOPIC - "DURING PROCEDURE WHILE SURGEON WAS ATTEMPTING TO APPLY CLIP TO CYSTIC DUCT AND ARTERY, THE CLIP APPLIER TRIGGER WOULD STICK WHEN SQUEEZED ALL THE WAY BACK TO PLASTIC HANDLE. CLIP CLOSURE WAS ACHIEVED AND THE SURGEON HAD TO USE TWO HANDS TO SEPARATE THE TRIGGER FROM THE HANDLE. HE STATED HE OFTEN HAS THIS PROBLEM WHEN USING THE CLIP APPLIER. HE WAS HOLDING THE CLIP APPLIER CORRECTLY. AFTER THE CASE, THE REPRESENTATIVE FIRED THREE CLIPS FROM THE APPLIER WITH NO PROBLEMS OR STICKING ISSUES." PATIENT STATUS: FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124574 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1169511

    Patients

    Seq Age Sex Outcome Treatment
    1