BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    MDR report key: 4211607 · Received October 29, 2014

    Report

    Report Number
    2027111-2014-00363
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 16, 2014
    Report Date
    December 1, 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

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT 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

    INVESTIGATION SUMMARY: 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. 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.

    Description of Event or Problem · 1

    LAP CHOLE- "ENDOSCOPIC BAG RUPTURED. GALL BLADDER AND CONTENTS INSIDE WERE SPILLED IN PATIENT'S ABDOMEN. CONTENTS REMOVED AND ABD WAS IRRIGATED UNTIL CLEAR IRRIGATION, WAS EVACUATED. THIRD BAG NOTED TO LET GO WITH MANUAL FORCE." ((B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692068 CD001, 10MM RETRIEVAL SYSTEM, 10/BX GCJ GCJ APPLIED MEDICAL CD001 1221801

    Patients

    Seq Age Sex Outcome Treatment
    1