BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 5059370 · Received September 6, 2015

    Report

    Report Number
    2027111-2015-00629
    Event Type
    Injury
    Date Received
    September 6, 2015
    Report Date
    September 4, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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, INCOMPLETE CLIP CLOSURE MAY OCCUR IF THE JAWS ARE CLOSED OVER A RIGID MATERIAL, SUCH AS ANOTHER CLIP OR STAPLE LINE, THE JAWS COULD DEFORM AND BE UNABLE TO FULLY CLOSE CLIPS. 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.

    Description of Event or Problem · 1

    LAP CHOLE- "SURGEON CLAIMS THAT THE CLIPS ARE NOT FULLY CLOSING AROUND THE DUCT AND VESSELS AND ARE FALLING OFF. SURGEON STATED HE HAD A PATIENT COME BACK TO THE OR BECAUSE A CLIP FELL OFF AND HIS DUCT WAS LEAKING. SURGEON STATES THAT THIS HAS HAPPENED A FEW TIMES OVER THE PAST MONTH. SURGEON WAS DR. (B)(6). " PATIENT STATUS: "PATIENT IS FINE NOW." TYPE OF INTERVENTION: "PATIENTS HAD TO BE BROUGHT BACK INTO THE OR SINCE THE CLIPS HAD FALLEN OFF, AND NEW CLIPS HAD TO BE PLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590661 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention