BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4152000 · Received October 8, 2014

    Report

    Report Number
    2027111-2014-00351
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 29, 2014
    Report Date
    December 30, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K060051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CLAMP PORTION OF THE BEAD OF THE UNIT WAS RETURNED FOR EVALUATION WITHOUT THE REST OF THE DEVICE. UPON INSPECTION, ENGINEERING FOUND THAT THE CLAMP WAS UNDAMAGED. IN THE ABSENCE OF THE REMAINING PARTS OF THE SUBJECT DEVICE IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. ALL INZII RETRIEVAL SYSTEMS UNDERGO 100% VISUAL INSPECTION DURING THE MANUFACTURING PROCESS. THROUGH PROPER USE OF THE DEVICE, THE CORD LOOP SHOULD REMAIN OUTSIDE OF THE PATIENT TO AID IN BAG REMOVAL. IF THE BAG AND CORD LOOP WAS PLACED OR FELL INSIDE OF THE PATIENT, AND THE TISSUE BAG WAS REMOVED BY GRABBING THE BAG ITSELF INSTEAD OF THE CORD LOOP, THEN IT IS POSSIBLE THAT THE BEAD MAY HAVE CAUGHT INTO THE PATIENT'S ABDOMINAL WALL AND DISLODGED FROM THE CORD LOOP. THE INSTRUCTIONS FOR USE (IFU) STATES, "REMOVE THE INDUCER SHEATH AND ROD, LEAVING THE BAG WITHIN THE CAVITY AND THE CORD ACCESSIBLE THROUGH THE TROCAR CANNULA; REMOVE THE TROCAR CANNULA FROM INCISION; REMOVE THE SPECIMEN BY PULLING ON THE CORD LOOP, THUS RETRACTING THE BAG THROUGH THE PORT SITE." APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS CONTINUOUS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE DEVICE ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO OCCUR. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    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.

    Description of Event or Problem · 1

    NEPHRECTOMY/PROSTECTECTOMY- "PATIENT HAD A NEPHRECTOMY ON (B)(6) 2014. PATIENT HAD A SECOND PROCEDURE ON (B)(6) 2014 AND IT WAS FOUND THAT THE PATIENT HAD A PIECE OF THE RETRIEVAL BAG FOUND INSIDE HIS ABDOMEN. SMALL GREEN CIRCULAR PLASTIC PIECE."- (B)(6) . I HAVE ATTACHED THEIR FEEDBACK FORM. THE FULL RETRIEVAL POUCH WAS UNAVAILABLE AS TO MY UNDERSTANDING THE ISSUE WAS UNRECOGNIZED FROM THE FIRST CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632627 CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX GCJ GCJ APPLIED MEDICAL CD004 1222975

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R