BEUDAMED
    FDA Adverse Event Injury Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 1964307 · Received January 19, 2011

    Report

    Report Number
    3005075853-2011-00257
    Event Type
    Injury
    Date Received
    January 19, 2011
    Report Date
    December 30, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SALES REP INDICATED THAT THE PATIENT IS DOING FINE. [SURGEON] COULD NOT DECIPHER WHERE THE LEAK WAS COMING FROM...[SURGEON] DOES NOT HAVE A SITE OF WHERE THE LEAK WAS COMING FROM. THE SURGEON INDICATED THAT THE ONLY THING THAT HAS CHANGED IN HIS COLECTOMY CASES IS THE USE OF THE NTLC.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT COLECTOMY PROCEDURE, THE DEVICE FIRED FINE WITH THE BLUE HEIGHT SELECTION AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. SOMETIME AFTER THE PROCEDURE, IT IS UNKNOWN WHEN, BUT THE PATIENT WAS TAKEN BACK INTO THE OR WITH A LEAK IN THE STAPLE LINE. THE LEAK WAS FIXED BUT IT IS UNKNOWN HOW THE LEAK WAS FIXED. THE PATIENT IS FINE. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    AFTER MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, NO FURTHER INFORMATION WAS 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 Other| R CARTRIDGE