BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELOADS FOR LINEAR CUTTERS

    MDR report key: 1822259 · Received December 7, 2007

    Report

    Report Number
    1527736-2007-08369
    Event Type
    Malfunction
    Date Received
    December 7, 2007
    Date of Event
    November 23, 2007
    Report Date
    November 27, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLE WAS MALFORMED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELOADS FOR LINEAR CUTTERS GDW ETHICON ENDO-SURGERY, INC (CINCINNATI) NA D4GF9X

    Patients

    Seq Age Sex Outcome Treatment
    1