BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PGX-35W 6.70MM X 3.90MM SKIN STAPLER

    MDR report key: 4620513 · Received March 16, 2015

    Report

    Report Number
    MW5041548
    Event Type
    Malfunction
    Date Received
    March 16, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 16, 2015
    Manufacturer
    3M
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE 3M PRECISE PGX-35W DISPOSABLE SKIN STAPLER WOULD NOT FIRE ANY STAPLES. ANOTHER "LIKE" STAPLER WAS UTILIZED WITHOUT PROBLEMS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177073 PRECISE PGX-35W 6.70MM X 3.90MM SKIN STAPLER SKIN STAPLER GDT 3M PGX-35W 2019-10JF

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR