BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX

    MDR report key: 5791967 · Received July 13, 2016

    Report

    Report Number
    2027111-2016-00524
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    May 25, 2016
    Report Date
    May 8, 2017
    Manufacturer
    AMR
    Product Code
    GCJ
    UDI-DI
    00607915126773
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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

    THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, ENGINEERING CONFIRMED THAT THE TISSUE BAG HAD A PUNCTURE NEAR THE DISTAL END. ENGINEERING'S ANALYSIS HAS DETERMINED THAT IT IS LIKELY THAT THE TISSUE BAG WAS EITHER PUNCTURED BY AN INSTRUMENT OR EXPOSED TO FORCES THAT WERE GREATER THAN WHAT THE BAG MATERIAL WAS ABLE TO WITHSTAND. IN THE INSTRUCTIONS FOR USE (IFU), IT IS STATED THAT "IF THE BAG AND ITS CONTENTS ARE TOO LARGE TO BE EXTRACTED, CAREFULLY ENLARGE THE PORT SITE FOR EASE OF BAG REMOVAL." APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.

    Description of Event or Problem · 1

    LOBECTOMY - "AFTER SURGERY, CLIENT MOVE THE SPECIMEN INTO THE BAG AND THEN THE BAG WAS BROKEN." PATIENT STATUS: "UNKNOWN".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM DISTRIBUTOR ON SEPTEMBER 7, 2016: THE TIP OF THE BAG WAS BROKEN. THE SURGEON WAS TRYING TO DEPLOY THE BAG WHEN THE BAG BROKE. A GRASPER WAS USED DURING INSERTION TO DEPLOY THE BAG. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM DISTRIBUTOR ON OCTOBER 20, 2016: "THE BAG WAS BROKEN WHEN THEY OPEN IT BEFORE PLACING THE SPECIMEN INTO THE BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445335 CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX GCJ GCJ AMR CD004 1263641 00607915126773

    Patients

    Seq Age Sex Outcome Treatment
    1 Other