BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM INZII RETRIEVAL SYSTEM 10/BOX

    MDR report key: 3952576 · Received July 23, 2014

    Report

    Report Number
    2027111-2014-00300
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 15, 2014
    Report Date
    September 26, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K060051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING CONFIRMED A SMALL TEAR NEAR THE BOTTOM OF THE BAG. THE BAG SHOWED SIGNS OF TENSION, CLEARLY VISIBLE IN THE STRETCHING NEAR THE BURST SITE. THE ROOT CAUSE OF THE INCIDENT IS LIKELY DUE TO USER ERROR. PREVIOUS TESTS HAVE SHOWN IDENTICAL STRETCHING AND BREAKING IN RETRIEVAL BAGS WHEN EXCESSIVE FORCE AND MANIPULATION IS USED TO REMOVE SPECIMENS FROM A SMALL INCISION; HOWEVER, FRAGMENTATION OF THE BAG HAS NOT BEEN OBSERVED DURING TESTING. THE INSTRUCTIONS FOR USE STATE, "NOTE: IF THE BAG AND ITS CONTENTS ARE TOO LARGE TO BE EXTRACTED, CAREFULLY ENLARGE THE PORT SITE FOR EASE OF BAG REMOVAL." WHEN THE INCISION IS ENLARGED, THE SPECIMEN CAN BE REMOVED WITHOUT INCIDENT. 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

    LAPAROSCOPIC APPENDECTOMY- "AT THE END OF THE PROCEDURE, SPECIMEN WAS BEING REMOVED AND BAG BURST." PATIENT STATUS: HEALTHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431905 10MM INZII RETRIEVAL SYSTEM 10/BOX CODE:GCJ GCJ APPLIED MEDICAL CD001 1213474

    Patients

    Seq Age Sex Outcome Treatment
    1