BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 4987534 · Received August 9, 2015

    Report

    Report Number
    2027111-2015-00460
    Event Type
    Malfunction
    Date Received
    August 9, 2015
    Date of Event
    June 23, 2015
    Report Date
    August 3, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER WAS PROVIDED. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF 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 DURING MANUFACTURING PRIOR TO PACKAGING. ALTHOUGH THE ROOT CAUSE OF YOUR EXPERIENCE COULD NOT BE DETERMINED, APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. 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 GASTRIC SLEEVE - "ACCOUNT REPORTS THAT DR. (B)(6) WAS USING THE CLIP APPLIER DURING A GASTRIC PROCEDURE AND SEVERAL OF THE CLIPS SCISSORED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521742 CA090, DIRECT DRIVE LCA 3/BX FZP APPLIED MEDICAL CA090 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1