BEUDAMED
    FDA Adverse Event Injury Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2011567 · Received March 9, 2011

    Report

    Report Number
    3005075853-2011-00936
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    December 2, 2010
    Report Date
    February 16, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THIS ACCOUNT WAS A NEW CONVERSION TO EES PRODUCTS. THIS WAS THE FIRST PROCEDURE THE SURGEON HAS USED THIS DEVICE [THE (B)(6) FOLLOWING (B)(6) 2010 ((B)(6) 2010).] 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 POST OP OF A COLON RESECTION PROCEDURE, THE PATIENT HAD A LEAK 4 TO 5 DAYS POST OP. THE PATIENT WAS RE-OPERATED ON AND THEN THE PATIENT WAS IN THE HOSPITAL (B)(6) AFTER THE RE-OPERATION. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 Hospitalization| O| R CARTRIDGE