BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 6365290 · Received February 28, 2017

    Report

    Report Number
    2027111-2017-00857
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    July 30, 2014
    Report Date
    February 28, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    UDI-DI
    00607915125318
    PMA / PMN Number
    8
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED FOR EVALUATION. THE UNIT WAS DISASSEMBLED AND INTERNAL COMPONENT DAMAGE WAS FOUND. THE ROOT CAUSE OF THE IMPROPER CLIP FIRING WAS CAUSED BY THE INTERFERENCE WITHIN THE INTERNAL COMPONENTS. 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. IN ACCORDANCE WITH 21 CFR 803.56, IF ADDITIONAL INFORMATION IS OBTAINED 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

    LAP CHOLE- "MISFIRED, CLIPS FALLING OUT BEFORE EVEN GETTING TO DUCT TO CLIP." PATIENT STATUS: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147490 EPIX UNIVERSAL CLIP APPLIER FZP FZP APPLIED MEDICAL RESOURCES 8 1222536 00607915125318

    Patients

    Seq Age Sex Outcome Treatment
    1