BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 2869465 · Received December 7, 2012

    Report

    Report Number
    2027111-2012-00379
    Date Received
    December 7, 2012
    Date of Event
    November 8, 2012
    Report Date
    December 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 CHOLECYSTECTOMY - "DR (B)(6) WAS LOADING THE CLIP CLEARLY AWAY FROM THE CYSTIC ARTERY AND THE CLIP JAMMED / FAILED IN THE DELIVERY. THE CLIP WENT SIDEWAYS AND JAMMED. HE PROCEEDED TO TRY AND CLOSE THE JAWS WHICH WAS UNSUCCESSFUL. REMOVAL OF THE CLIP APPLIER WAS AN EFFORT AND TIME CONSUMING. WHEN THIS HAPPENED THERE WAS ONE CLIP THAT SPAT OUT OF THE JAWS AND NEED TO BE FOUND WITHIN THE ABDOMEN POST REMOVAL. A 5MM CLIP APPLIER WAS FROM A 5MM SOLUTION KIT (B)(4) (LOT 1181680)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1167848

    Patients

    Seq Age Sex Outcome Treatment
    1 CA500 CLIP APPLIER