BEUDAMED
    FDA Adverse Event Injury Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2012174 · Received March 9, 2011

    Report

    Report Number
    3005075853-2011-00943
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 10, 2011
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: THE ACCOUNT IS UNDER AN INVESTIGATION, HAS REQUESTED INFORMATION AND IS TRYING TO FIGURE OUT DETAILS. ACCOUNT ALSO INDICATED THAT THEY HAVE BEEN ADVISED BY THEIR LEGAL PARTNERS TO NOT GIVE ANY INFORMATION. EES WAS PRESENT FOR THE PROCEDURES SINCE THE ACCOUNT WAS CONDUCTING A TRIAL ON THE DEVICE. THE ACCOUNT WAS USING THE GIA AND COVIDIEN DEVICES BEFORE (B)(6) 2010. THE EES REP WAS NOT COMMUNICATED OR MADE AWARE OF THIS POST-OP LEAK. THERE ARE NO DETAILS AVAILABLE. 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 Manufacturer Narrative · 1

    (B)(4): DESPITE NUMEROUS ATTEMPTS TO RISK MANAGEMENT FOR ADDITIONAL INFORMATION, NO RESPONSE HAS BEEN RECEIVED. IT WAS ALSO DETERMINED THAT THE USER FACILITY MEDWATCH (UFM), INITIALLY SENT UNDER REPORT # 3005075853-2011-01614, BELONGS TO THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP OF A GENERAL SURGICAL PROCEDURE, THE PATIENT HAD A POST OP ANASTOMOTIC LEAK. NO OTHER DETAILS WERE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R CARTRIDGE