BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 6395597 · Received March 10, 2017

    Report

    Report Number
    2027111-2017-01577
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    June 1, 2014
    Report Date
    March 10, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    UDI-DI
    00607915117306
    PMA / PMN Number
    K011236
    Removal / Correction Number
    Z-1621-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DATE OCCURRED IN (B)(6) 2014, NO SPECIFIC DATE WAS NOTED. ANOTHER POSSIBLE LOT NUMBER WAS MENTIONED, LOT # 1213264. THE UDI, MANUFACTURING/EXPIRATION DATES ARE LISTED BELOW. THE PRODUCT CODE AND 510(K) CODE IS THE SAME. MANUFACTURING DATE: 01/27/2014 EXPIRATION DATE: 01/26/2017 UDI: (B)(4). ON MARCH 18, 2016, APPLIED MEDICAL ISSUED A VOLUNTARY CLASS II RECALL OF THE CA090 DIRECT DRIVE CLIP APPLIER DUE TO INCREASED CUSTOMER FEEDBACK INDICATING INCONSISTENT CLIP APPLICATION, WHICH HAS THE POTENTIAL TO LEAD TO UNOCCLUDED VESSELS. AN INTERNAL CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN INITIATED TO CONDUCT A THOROUGH INVESTIGATION AND IMPLEMENT APPROPRIATE CORRECTIVE ACTIONS. FDA HAS ISSUED RECALL NUMBER Z-1621-2016 FOR THIS RECALL. THIS REPORT IS BEING FILED AS A RESULT OF A RE-REVIEW OF APPLIED MEDICAL COMPLAINTS RECEIVED BETWEEN JUNE 1, 2014 AND MAY 31, 2016. THIS RETROSPECTIVE REVIEW WAS ASSOCIATED WITH A QUALITY MANAGEMENT SYSTEM (QMS) COMPLIANCE ACTION PLAN DEVELOPED AND PRESENTED TO FDA TO ADDRESS AN APRIL 10, 2015 WARNING LETTER. APPLIED MEDICAL HAS REVISED ITS MDR REPORTING CRITERIA TO BE MORE CONSERVATIVE AND HAS IMPROVED COMPLAINT HANDLING AND MDR REPORTING PROCESSES. THE REVIEWS ENSURED THAT RECENT REPORTABLE EVENTS WERE APPROPRIATELY IDENTIFIED AND REPORTED TO THE DESIGNATED REGULATORY AUTHORITY(IES). THIS REPORT, WHICH REPRESENTS THE INITIAL AND FINAL REPORTS COMBINED, IS BEING SUBMITTED BASED ON THE FINDINGS OF THAT RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    LAP CHOLE- "4 EVENTS REPORTED WITH 4 DIFFERENT CLIP APPL, 2 DIFFERENT LOTS. NOT REPORTED SPECIFIC MALFUNCTION ASSOCIATED TO PROD. LOTS REPORTED ARE 1213391 AND 1213264 ( PLEASE REFER TO CER PORRETTA 3,4). THE SURG REPORTED NO FIRING OF CLIP AND NO COMPLETE CLOSURE/ WRONG CLOSURE OF THE CLIP AFTER FIRING. INTERVENTION WAS COMPLETED WITH A DIFFERENT BLAND CLIP APPLIER. NOT POSSIBLE TO RETIRE THE SAMPLES FOR INSPECTION BECAUSE THE EVENT WAS REPORTED TO ITALIAN MINISTRY OF HEALTH, SO PRODUCTS HAVE TO REMAIN AVAILABLE FOR MINISTRY EXAMINATION." PATIENT STATUS: GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178316 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL RESOURCES CA090 1213391 00607915117306

    Patients

    Seq Age Sex Outcome Treatment
    1 NEW CLIP APPLIER FROM DIFFERENT BRAND| XCEL ETHICON TROCAR DILATING TIP