BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3030442 · Received March 26, 2013

    Report

    Report Number
    2027111-2013-00108
    Date Received
    March 26, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 26, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 CHOLECYSTECTOMY: "THE CLIP APPLIER WOULD NOT DELIVER AND OCCLUDE A CLIP WHILE ATTEMPTING TO PERFORM LIGATION CYSTIC VESSELS NECESSARY IN THE REMOVAL OF THE GALL BLADDER." PATIENT STATUS: "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124805 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1182277

    Patients

    Seq Age Sex Outcome Treatment
    1 TROCARS| STANDARD LAPAROSCOPIC INSTRUMENTS