BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 45-3.5 DLU W/HANDLE (FRANCE)

    MDR report key: 774812 · Received October 27, 2006

    Report

    Report Number
    1219930-2006-00429
    Event Type
    Injury
    Date Received
    October 27, 2006
    Date of Event
    August 31, 2006
    Report Date
    August 31, 2006
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED 10/18/2006 FROM TYCO FRANCE, THIS REPORT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT. THEREFORE, THE EVENT HAS BEEN RECORDED AND THIS MDR REPORT HAS BEEN DRAFTED AFTER THE ORIGINAL REPORT DATE.

    Description of Event or Problem · 1

    PROCEDURE: COLECTOMY; PATIENT SEX: UNK, THE ORIGINAL REPORT IN 2006 STATED, THE INSTRUMENT COULD NOT BE FIRED AT ALL AND WAS DESIGNATED AS A NON ADVERSE EVENT. HOWEVER, UPON REPEATED FOLLOW UP INQUIRIES WITH THE EVENT REPORTER, IT WAS REPORTED ON 10/18/2006, THAT, THE INSTRUMENT WAS APPLIED ON TISSUE, BUT IT WOULD NOT STAPLE AND IT COULD NOT BE REOPENED. THIS LEAD TO TORN TISSUE WITH REQUIRED SUTURING. BASED ON THIS ADDITIONAL INFORMATION AND CLARIFICATION, THESE EVENT WAS RECLASSIFIED AS AN ADVERSE EVENT AND AN MDR WAS DRAFTED AFTER THE ORIGINAL REPORT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 45-3.5 DLU W/HANDLE (FRANCE) DISPOSABLE SURGICAL STAPLER GCJ NORTH HAVEN - USS * N6A75

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention