BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX

    MDR report key: 6374841 · Received March 2, 2017

    Report

    Report Number
    2027111-2017-01042
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    September 3, 2015
    Report Date
    March 2, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    UDI-DI
    00607915125318
    PMA / PMN Number
    13
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING DETERMINED THAT THE UNIT FUNCTIONED PROPERLY. THE ROOT CAUSE COULD NOT BE DETERMINED AS ENGINEERING WAS UNABLE REPLICATE THE INCIDENT. 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

    PROCEDURE PERFORMED UNKNOWN - "ONE UNIT FIRED TWO CLIPS AT ONCE. THE OTHER MALFUNCTIONED COMPLETELY." PATIENT STATUS - "PATIENT NOT HARMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157428 CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX FZP FZP APPLIED MEDICAL RESOURCES 13 1247833 00607915125318

    Patients

    Seq Age Sex Outcome Treatment
    1