BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M PRECISE VISTA

    MDR report key: 8767744 · Received July 5, 2019

    Report

    Report Number
    MW5087902
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 28, 2019
    Report Date
    July 2, 2019
    Manufacturer
    3M HEALTH CARE/ MEDLINE INDUSTRIES, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SKIN STAPLER BROKE DURING TOTAL KNEE REPLACEMENT SURGERY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558884 3M PRECISE VISTA STAPLER, SURGICAL GAG 3M HEALTH CARE/ MEDLINE INDUSTRIES, INC. 3995-35W 202404JS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR