BEUDAMED
    FDA Adverse Event Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 2985174 · Received October 15, 2012

    Report

    Report Number
    2027111-2012-00301
    Date Received
    October 15, 2012
    Date of Event
    June 25, 2012
    Report Date
    October 15, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVAL. UPON INSPECTION, ENGINEERING FOUND THAT THE COMPONENT, WHICH LOADS THE CLIP INTO THE JAW, HAD SUSTAINED DAMAGE. THIS DAMAGE PREVENTED THE CLIP FROM BEING ADVANCED INTO THE JAWS CORRECTLY, WHICH MAY HAVE CONTRIBUTED TO YOUR EXPERIENCE. THE EXACT CAUSE OF THE DAMAGE IS UNK. ALL CLIP APPLIERS UNDERGO 100% VISUAL AND FUNCTIONAL INSPECTION DURING THE MFG AND ASSEMBLY. AS A PART OF THIS PROCESS, EACH UNIT IS INSPECTED FOR CLIP FEEDING DURING MFG PRIOR TO PACKAGING. FOR OPTIMAL PERFORMANCE OF THE CLIP APPLIER, USE CARE WHEN REMOVING THE DEVICE FROM PACKAGING AND WHEN INTRODUCING OR REMOVING THE DEVICE THROUGH A TROCAR. DURING CLIP APPLICATION, VERIFY THAT THE LIGATION SITE IS FREE OF OBSTRUCTIONS OR OTHER BEFORE FIRING THIS DOCUMENT REPRESENTS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    LAP CHOLE - "DURING LAP CHOLE, THE DOCTOR BEGAN TO ENGAGE CLIP APPLIER. THE CLIP DID NOT LOAD UPON INITIAL PHASE OF PULLING THE HANDLE. WHEN THE DOCTOR FULLY ENGAGED THE HANDLE; A SERIES OF CLIPS "FIRED INTO THE PT". ALL THE CLIPS WERE RETRIEVED FROM THE PT." MEDWATCH # 340010-201253 RECEIVED 10/02/2012. DESCRIBED EVENT OR PROBLEM: "THE PT IN SURGERY ON (B)(6) 2012 FOR A "LAPAROSCOPIC CHOLECYSTECTOMY" WITH A POST SURGERY DIAGNOSIS OF "LEFT OVARIAN CYST". THE SURGEON'S DOCUMENTATION REVEALED "CYSTIC DUCT AND CYSTIC ARTERY WERE IDENTIFIED, INDIVIDUALLY HEMOCLIPPED TIMES 3 AND DIVIDED. ANOTHER SMALL POSTERIOR BRANCH OF THE CYSTIC ARTERY WAS LIKEWISE CLIPPED TIMES 3 AND DIVIDED." THE EVENT WAS REPORTED AS THE 5MM ENDOCLIP APPLIER STAPLER / CLIPPER WOULD NOT FIRE DURING THE SURGERY. THERE WAS NO REPORTED INJURY TO THE PT IN THE REPORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1166689

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention