BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 4988413 · Received August 10, 2015

    Report

    Report Number
    2027111-2015-00519
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 7, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: TWO (2) EVENT UNITS WERE RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING FOUND THAT THE JAWS WERE NOT PARALLEL. ENGINEERING WAS ABLE TO REPLICATE YOUR EXPERIENCE OF CLIP SCISSORING. THIS DAMAGE MAY PREVENT THE CLIPS FROM CLOSING COMPLETELY. UPON INSPECTION OF THE SECOND UNIT, ENGINEERING DETERMINED THAT THE UNIT FUNCTIONED PROPERLY. THE CLIPS WERE FIRED OFF ONE AT A TIME AND CONFORMED TO ALL SPECIFICATIONS. THE EXACT CAUSE OF THE MISALIGNMENT IS UNKNOWN. 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. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS. A PART OF THIS CONTINUOUS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING MANUFACTURING PROCESS AND INSPECTION ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO OCCUR. 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

    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.

    Description of Event or Problem · 1

    LAP. CHOLECYSTECTOMY- "THE SURGEON AFTER THE FAILURE OF CLIP APPLIER INSIDE THE LAP CHOLE KIT, (SEE (B)(4)), OPENED ANOTHER ONE FROM A SEPARATE BOX BUT THE CLIPS WERE SCISSORING AND CUTTING THE TISSUE. THE SURGEON FINALLY OPENED ANOTHER DEVICE- SAME LOT. 1237566 - AND THIS TIME IT WORKED. THEY KEPT ALL THE SAMPLES, BUT UNFORTUNATELY ALL MIXED UP, SO IT'S NO LONGER POSSIBLE TO DISTINGUISH WHICH DIRECT DRIVE IS WORKING OF THE LOT 1237566. THEY FILMED THE SURGERY, SO WE'LL BE ABLE TO SEE THE FILM LATER." TYPE OF INTERVENTION- "THE SURGEON NEEDED TO TAKE OUT ALL THE MISSHAPED CLIPS AND USE ANOTHER APPLIER." PATIENT STATUS- "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521820 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 1237566

    Patients

    Seq Age Sex Outcome Treatment
    1