BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3032813 · Received March 25, 2013

    Report

    Report Number
    2027111-2013-00087
    Date Received
    March 25, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 22, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST REC'D THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVAL. A F/U REPORT WILL BE SENT 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

    LAPAROSCOPIC CHOLECYSTECTOMY - "DR (B)(6) WERE/HAVE BEEN PROPERLY IN-SERVICED ON DEVICE. CA 500 WAS INSERTED INTO SUBXIPHOID ADV FIX TROCAR. DR (B)(6) ENGAGED TRIGGER TO "INITIATE LOADING AND FULL CYCLE SEQUENCE." CLIP WAS SECURELY CLOSED TO PROXIMAL, CYSTIC DUCT BUT TRIGGER REMAINED CLOSED POSITION. DR (B)(6) HAD TO MANUALLY 'RELEASE' THE TRIGGER AFTER EACH COMPLETE CLIP SEQUENCE; APPROX 7-8 CLIPS. DR (B)(6) COMPLAINED ABOUT THIS FEATURE." PT STATUS: NORMAL/FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123043 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1166694

    Patients

    Seq Age Sex Outcome Treatment
    1