BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 2243452 · Received September 12, 2011

    Report

    Report Number
    3005075853-2011-03750
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOID PROCEDURE, THERE WAS A STAPLE LINE LEAKAGE. DURING A SIGMOID PROCEDURE (B)(6), THE DEVICE WAS USED ON RECTUM-COLON. THE SURGEON CUT, STAPLED, THEN DID THE ANASTOMOSIS. NO UNEXPECTED NOISE WAS HEARD. NO RESISTANCE WAS FELT BY THE SURGEON. AFTER USE, ALL BUTTONS AND TRIGGERS RETURNED TO THEIR ORIGINAL PLACE. THE SURGEON HAD NO DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT'S TISSUES. NO BUTTRESSING MATERIAL WAS USED. THE CARTRIDGE USED WAS BLUE AND IT WAS THE FIRST ONE. THE TISSUE STAPLED WAS NEVER BEEN RADIATED. ON (B)(6), THE PATIENT PRESENTED A TRANSRECTAL HEMORRHAGE WITH HEMOGLOBIN AT 10 G/DL. THE PATIENT DID NOT HAVE TO GET BLOOD TRANSFUSION. THE SURGEON DID A WASHING OF THE CLOT IN ICE WATER. THE PATIENT WAS DISCHARGED AND IS FINE TODAY. ONE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION BEING REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED ON (B)(4) 2011 BUT NO MORE INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H43Z3C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R