BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 4250946 · Received November 14, 2014

    Report

    Report Number
    3005075853-2014-07914
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    November 5, 2014
    Report Date
    November 6, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED: THERE WAS NO PATIENT CONSEQUENCE. POST-OP CARE WAS NORMAL.

    Additional Manufacturer Narrative · 1

    (B)(4), INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED: THERE WAS NO PATIENT CONSEQUENCE. POST-OP CARE WAS NORMAL.

    Description of Event or Problem · 1

    CALL FROM RN WITH PATIENT ON TABLE FOR A TAKEDOWN COLOSTOMY WITH COLORECTAL ANASTOMOSIS/SMALL BOWEL RESECTION PROCEDURE. SURGEON REPORTED THAT DEVICE IS NOT WORKING PROPERLY, AS THE ANVIL AND TROCAR PORTIONS WERE NOT STAYING ENGAGED WITH EACH OTHER. ASSISTED SURGEON WITH TROUBLESHOOTING DEVICE AND ADVISED THAT THE TROCAR PORTION OF A NEW LIKE DEVICE MAY BE OPENED AND USED WITH THE ANVIL PORTION ALREADY PLACED IN PATIENT. A NEW LIKE DEVICE WAS OPENED, AND THE SURGEON COMPLETED THE PROCEDURE WHILE CSA EXPLAINED STEPS FOR USE VIA PHONE. THE TISSUE DONUTS WERE EXAMINED FOR INTEGRITY, AND AN AIR TEST WAS PERFORMED WITH NO LEAKAGE NOTED. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS, AS THE CUSTOMER DISPOSED OF IT.

    Description of Event or Problem · 1

    CALL FROM RN WITH PATIENT ON TABLE FOR A TAKEDOWN COLOSTOMY WITH COLORECTAL ANASTOMOSIS/SMALL BOWEL RESECTION PROCEDURE. SURGEON REPORTED THAT DEVICE IS NOT WORKING PROPERLY, AS THE ANVIL AND TROCAR PORTIONS WERE NOT STAYING ENGAGED WITH EACH OTHER. ASSISTED SURGEON WITH TROUBLESHOOTING DEVICE AND ADVISED THAT THE TROCAR PORTION OF A NEW LIKE DEVICE MAY BE OPENED AND USED WITH THE ANVIL PORTION ALREADY PLACED IN PATIENT. A NEW LIKE DEVICE WAS OPENED, AND THE SURGEON COMPLETED THE PROCEDURE WHILE CSA EXPLAINED STEPS FOR USE VIA PHONE. THE TISSUE DONUTS WERE EXAMINED FOR INTEGRITY, AND AN AIR TEST WAS PERFORMED WITH NO LEAKAGE NOTED. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS, AS THE CUSTOMER DISPOSED OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737732 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EW1W

    Patients

    Seq Age Sex Outcome Treatment
    1