BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 4006693 · Received August 13, 2014

    Report

    Report Number
    2027111-2014-00321
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    July 28, 2014
    Report Date
    March 24, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. ENGINEERING INSPECTED THE UNIT FROM LOT 1222176, UPON ACTUATION; ALL REMAINING CLIPS LOADED AND FIRED OFF CORRECTLY. THE UNIT WAS DISASSEMBLED, ENGINEERING FOUND INTERNAL COMPONENT DAMAGE. THE ROOT CAUSE COULD NOT BE DETERMINED AS ENGINEERING WAS UNABLE TO REPLICATE THE INCIDENT.; THE INTERNAL COMPONENT DAMAGE IS UNRELATED TO THE INCIDENT. ALL CLIP APPLIERS UNDERGO 100% VISUAL AND FUNCTIONAL INSPECTION DURING THE MANUFACTURING AND ASSEMBLY PROCESS. AS A PART OF THIS PROCESS, EACH UNIT IS INSPECTED FOR CLIP FEEDING AND CLOSURE DURING MANUFACTURING PRIOR TO PACKAGING. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Description of Event or Problem · 1

    LAP CHOLE- "DR. (B)(6) WAS PERFORMING LAP CHOLE WITH 1X1MM PORT AND 3X5MM PORTS. DR. IDENTIFIED CYSTIC DUCT OR CYSTIC ARTERY. DR. FIRED CLIP IN ONE SINGLE MOTION. CLIP FIRED SEVERAL GOOD CLIPS THEN STARTED SPITTING CLIPS. I MENTIONED THAT THE DEVICE COULD MISFIRE IF GRIP WAS DOSED RAPIDLY AND RECOMMEND DEVICE BE REMOVED AND TEST FIRED SEVERAL TIMES BEFORE CONTINUING, HE DID SO AND IT CONTINUED TO MISFIRE. I RECOMMEND WE OPEN NEW DEVICE. WE DID. SECOND CLIP FIRED ONE CLIP AND THEN MISFIRED. DR. ASKED FOR 5MM PORT TO BE ADDED TO RETRACT AUMENTUIM TO INSPECT CLIPS. DR ASKED FOR ADDITIONAL 11MM PORT AND REUSABLE CLIP APPLIER AND YELLOW CLIPS. BLOOD WAS POOLING AT BASE OF GALLBLADDER. COULD NOT FIND SOURCE OF BLEEDING. DR. CONVERTED TO OPEN. COORDINATOR TOLD ME THAT DR. THINKS CLIP APPLIER SCISSORED ARTERY." TYPE OF INTERVENTION- "CONVERTED TO OPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481884 EPIX UNIVERSAL CLIP APPLIER FZP FZP APPLIED MEDICAL CA500 1222176

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R ADD 2 EXTRA PORTS THEN OPENED (CONVERTED TO OPEN)