BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE SKIN STAPLER 35W

    MDR report key: 5105016 · Received September 21, 2015

    Report

    Report Number
    MW5056505
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 18, 2015
    Report Date
    September 21, 2015
    Manufacturer
    3M
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    THREE M PGX 35W STAPLER WOULD NOT FIRE. DIAGNOSIS OR REASON FOR USE: SURGICAL PROCEDURE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED, NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623565 PRECISE SKIN STAPLER 35W SKIN STAPLER GDW 3M PGX 35W 2020-05JL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR