BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 5112617 · Received September 30, 2015

    Report

    Report Number
    2027111-2015-00693
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 29, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Removal / Correction Number
    FDA# PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    UDI# PROVIDED. INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING TESTED THE UNIT FOR FUNCTIONALITY AND EXPERIENCED IMPROPER CLIP LOADING SIMILAR TO THE CUSTOMER'S EXPERIENCE. THE UNIT WAS DISASSEMBLED AND AN INTERNAL COMPONENT WAS FOUND DAMAGED. THE ROOT CAUSE OF THE IMPROPER CLIP LOADING WAS LIKELY THE DAMAGE TO THE INTERNAL COMPONENT WHICH PREVENTED THE DEVICE FROM RESETTING PROPERLY. THIS DAMAGE COULD LEAD TO INCREASED INTERFERENCE DURING ACTUATION, POTENTIALLY LEADING TO IMPROPER CLIP LOADING AND CLOSURE. THE ROOT CAUSE OF THE DAMAGE REMAINS UNKNOWN; HOWEVER, IT MAY HAVE OCCURRED DURING MANUFACTURING. ON MARCH 18, 2016, APPLIED MEDICAL ISSUED A VOLUNTARY RECALL OF THE CA090 DIRECT DRIVE® CLIP APPLIER DUE TO INCREASED CUSTOMER FEEDBACK INDICATING INCONSISTENT CLIP APPLICATION. ALTHOUGH MALFORMED CLIPS ARE TYPICALLY READILY APPARENT TO THE USER, THIS FAILURE MODE MAY LEAD TO UNOCCLUDED VESSELS. WE REGRET THIS DISRUPTION IN SUPPLY, YET BELIEVE THAT THIS IS IN THE BEST INTEREST OF OUR CUSTOMERS. THE LOT REPORTED TO US IN YOUR EXPERIENCE REPORT, #1238425, WAS INCLUDED IN THE RECALL. 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 A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." COMPLAINT SHEET -"THE FIRST AND SECOND CLIPS WOULD NOT BE LOADED OR CLOSED PROPERLY DURING A PROCEDURE. INSTRUMENTS COMBINED: (B)(4). THE EVENT UNIT WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED: NO VISIBLE DAMAGE WAS FOUND WITH THE UNIT. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. (B)(4)." PATIENT STATUS - "NO PATIENT INJURY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644473 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 1238425

    Patients

    Seq Age Sex Outcome Treatment
    1