BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER - 30 MM

    MDR report key: 1100084 · Received August 5, 2008

    Report

    Report Number
    3005075853-2008-00913
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 11, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLES DID NOT CLOSE ALL THE WAY. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER - 30 MM GDW ETHICON ENDO-SURGERY, LLC NA V45313K

    Patients

    Seq Age Sex Outcome Treatment
    1