BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 5010814 · Received August 18, 2015

    Report

    Report Number
    2027111-2015-00565
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Report Date
    August 18, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE INCIDENT PRODUCT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. ALTHOUGH THE ROOT CAUSE OF YOUR EXPERIENCE COULD NOT BE DETERMINED, CLIP SCISSORING AS EXPERIENCED BY THE CUSTOMER, MAY HAVE BEEN THE RESULT OF THE APPLICATION STRUCTURE SIZE OR THE LOCATION OF THE VESSEL WITHIN THE CLIP, WHICH PREVENTED PROPER CLIP CLOSURE. 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. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    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 BYPASS- "CLIPS DO NOT STAY IN PLACE, FALL OFF, CROSS OVER, SCISSORING EFFECT. THE CLIPS WERE PLACED OVER THE STAPLER LINE DURING LAP GASTRIC BYPASS. THE EVENT HAPPENED IN THREE PATIENTS IN (B)(6)." PATIENT STATUS - "HEALTHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546307 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1