BEUDAMED
    FDA Adverse Event Death Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 1844572 · Received September 20, 2010

    Report

    Report Number
    3005075853-2010-05352
    Event Type
    Death
    Date Received
    September 20, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. EVALUATION SUMMARY. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE, NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. ADDITIONAL INFORMATION RECEIVED ON 8/24/2010: THE PT MAY HAVE POSSIBLY TAKEN HIGH DOSES OF STEROIDS IN THE PAST. THIS MAY HAVE COMPROMISED THE TISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION WAS RECEIVED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A RIGHT COLECTOMY. POST-OPERATIVELY THREE DAYS, THE PT BECAME SEPTIC AND DIED. THE PT WAS EXPLORED FOR REASON OF SEPSIS AND IT APPEARED TO BE WHERE THE NTLC WAS USED; THE STAPLE LINE BROKE DOWN AT THE PROXIMAL END. IT IS UNK IF THE SURGEON TRIED TO REPAIR PRIOR TO PT EXPIRING. THE SIDE TO SIDE ANASTOMOSIS IS CREATED BY USING THE NTLC AND THE TLH90. IT IS UNK IF AN AUTOPSY WILL BE PERFORMED. THE DEVICES WERE DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| R CARTRIDGE