BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE

    MDR report key: 4745526 · Received April 27, 2015

    Report

    Report Number
    MW5042447
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 27, 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

    DURING THE CLOSURE PORTION OF THE SURGICAL PROCEDURE, THE 3M PRECISE PGX-35W SKIN STAPLER JAMMED AND BECAME NON-FUNCTIONAL. REASON FOR USE: SKIN CLOSURE OF SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275099 PRECISE SKIN STAPLER GDT 3M PGX-35W 2020-01JM

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR