BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER -30MM

    MDR report key: 1822282 · Received December 6, 2007

    Report

    Report Number
    1527736-2007-08335
    Event Type
    Malfunction
    Date Received
    December 6, 2007
    Report Date
    November 26, 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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE DEVICE DID NOT STAPLE. THE SURGEON HAD TO COMPLETE THE OPERATION MANUALLY. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER -30MM GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HP15

    Patients

    Seq Age Sex Outcome Treatment
    1