BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    MDR report key: 4211647 · Received October 29, 2014

    Report

    Report Number
    2027111-2014-00364
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 16, 2014
    Report Date
    February 14, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. 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

    THE EVENT UNIT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE. IN THE ABSENCE OF THE SUBJECT DEVICE, IT CAN BE DIFFICULT TO DETERMINE THE ROOT CAUSE. ALTHOUGH THE ROOT CAUSE OF THE EXPERIENCE COULD NOT BE DETERMINED, APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. 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 TO 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE COMPLETE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT REVEALS THE LOT PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATE, THE ACTUATION ROD MUST BE PUSHED COMPLETELY FORWARD UNTIL IT HAS REACHED ITS ADVANCING ENDPOINT, WHICH IS INDICATED BY A STOP. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED UNKNOWN - DURING USE OF THE DEVICE THE SMALL PIECE OF PLASTIC ATTACHED TO THE BAG. STRING STAYED TIGHT. THIS PREVENTED THE EXTRACTION OF THE BAG. ENLARGEMENT OF THE PARIETAL OPENING TO REMOVE THE PIECE."

    Description of Event or Problem · 1

    UNKNOWN- DURING USE OF THE DEVICE THE SMALL PIECE OF PLASTIC ATTACHED TO THE BAG. STRING STAYED TIGHT. THIS PREVENTED THE EXTRACTION OF THE BAG. ENLARGEMENT OF THE PARIETAL OPENING TO REMOVE THE PIECE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691677 CD001, 10MM RETRIEVAL SYSTEM, 10/BX GCJ GCJ APPLIED MEDICAL RESOURCES CD001 1218544

    Patients

    Seq Age Sex Outcome Treatment
    1