BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3830806 · Received May 23, 2014

    Report

    Report Number
    2027111-2014-00261
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 9, 2014
    Report Date
    August 1, 2014
    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

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING FOUND A DENT IN THE SHAFT OF THE DEVICE NEAR THE KNOB AND CONFIRMED YOUR EXPERIENCE WITH THE DEVICE. THE UNIT WAS DISASSEMBLED FOR FURTHER EVALUATION AND ALL INTERNAL COMPONENTS MET SPECIFICATIONS. THE ROOT CAUSE OF THE JAWS LOCKING IS DUE TO THE BEND IN THE SHAFT OF THE DEVICE, WHICH PREVENTED INTERNAL COMPONENTS FROM MOVING PROPERLY. 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 DURING MANUFACTURING PRIOR TO PACKAGING. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    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 CHOLE- "AS PER (B)(6), DOCTOR ATTEMPTED TO APPLY CLIP ONTO THE CYSTIC DUCT AND WHEN SHE SQUEEZED THE TRIGGER THE JAWS CLOSED ONTO THE DUCT AND WOULD NOT REOPEN. IT STAYED LOCKED ON THE DUCT. SHE TRIED TO SQUEEZE TRIGGER AGAIN TO RELEASE AND A CLIP FELL OUT OF THE APPLIER." PATIENT STATUS: "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307427 EPIX UNIVERSAL CLIP APPLIER CLIP, IMPLANTABLE, CODE:FZP FZP APPLIED MEDICAL CA500 1214342

    Patients

    Seq Age Sex Outcome Treatment
    1 Other