BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE PGX 35W

    MDR report key: 6352525 · Received February 21, 2017

    Report

    Report Number
    MW5068025
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    February 20, 2017
    Report Date
    February 21, 2017
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRECISE PGX 35W SKIN STAPLER FROM MEDLINE PLASTICS MAJOR PACK JAMMED DURING TRIGGER PULL, NOT RELEASING A STAPLE. SUBSEQUENT TRIGGER PULLS RESULTED IN FAILED STAPLE RELEASES AS WELL. THE PRECISE PGX 35W SKIN STAPLER WAS A COMPONENT INCLUDED IN A MEDLINE PLASTICS MAJOR PACK, #DYNJ49360, LOT # 16IB9846.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129907 PRECISE PGX 35W SKIN STAPLER GAG MEDLINE INDUSTRIES DYNJ49360 16IB9846

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR