BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 5010919 · Received August 18, 2015

    Report

    Report Number
    2027111-2015-00561
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 22, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. ENGINEERING ACTUATED THE UNIT AND DETERMINED THAT THE UNIT FUNCTIONED PROPERLY. THE CLIPS WERE FIRED OFF ONE AT A TIME AND CONFORMED TO ALL SPECIFICATIONS. ENGINEERING ACTUATED THE UNIT AT DIFFERENT ANGLES ON TUBING TO ATTEMPT TO REPLICATE THE CUSTOMERS' EXPERIENCE OF CLIPS CROSSING. THE UNIT WAS DISASSEMBLED FOR FURTHER EVALUATION AND MET ALL SPECIFICATIONS. THE ROOT CAUSE OF THE SCISSORING 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. ENGINEERING WAS ABLE TO RECREATE THE CLIP MISALIGNMENT AT ADVERSE APPLICATION ORIENTATIONS. 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 AND CLOSURE 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

    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

    UNKNOWN- "USER REPORTED CROSSED CLIP DURING USE OF THE DEVICE ON NORMAL TISSUE. PATIENT STATUS - "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546075 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 1240611

    Patients

    Seq Age Sex Outcome Treatment
    1