BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THOR ENDO LIN CUT THK

    MDR report key: 1820729 · Received September 20, 2007

    Report

    Report Number
    1527736-2007-06224
    Event Type
    Malfunction
    Date Received
    September 20, 2007
    Date of Event
    August 31, 2007
    Report Date
    September 13, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACIC PROCEDURE AFTER THE DEVICE WAS FIRED THERE WAS AN INCOMPLETE STAPLE LINE. THE CASE WAS COMPLETED WITH SUTURING OF THE UNSTAPLED LUNG WITH NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THOR ENDO LIN CUT THK GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HV58

    Patients

    Seq Age Sex Outcome Treatment
    1