BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURSTRING

    MDR report key: 3885618 · Received June 9, 2014

    Report

    Report Number
    3885618
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    COVIDIEN LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PURSTRING DEVICE (REF#020242) DID NOT FUNCTION CORRECTLY. IT WOULD NOT RELEASE THE STITCH. THEY KEPT WORKING WITH IT AND EVENTUALLY HAD TO BREAK THE STITCH OFF. THE SURGEON KEPT WORKING WITH THE INSTRUMENT AND EVENTUALLY HAD TO BREAK THE STITCH OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336580 PURSTRING STAPLE, IMPLANTABLE GDW COVIDIEN LLC 020242 P3M0412X

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR