BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE VASCULAR LINEAR STAPLER - 30 MM

    MDR report key: 1831427 · Received December 17, 2007

    Report

    Report Number
    1527736-2007-08559
    Event Type
    Malfunction
    Date Received
    December 17, 2007
    Date of Event
    December 5, 2007
    Report Date
    December 6, 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
    FR
    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 AN UNKNOWN PROCEDURE, THE DEVICE WOULD NOT STAPLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE VASCULAR LINEAR STAPLER - 30 MM GDW ETHICON ENDO-SURGERY, INC (CINCINNATI) NA D4JD6Y

    Patients

    Seq Age Sex Outcome Treatment
    1