BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 20245267 · Received September 18, 2024

    Report

    Report Number
    20245267
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    April 29, 2024
    Report Date
    June 6, 2024
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SEAMGUARD MISSING. HAS BEEN REPORTED & RETURNED, RGA# [REDACTED], TRACKING # [REDACTED]. MANUFACTURER RESPONSE FOR STAPLE RELOAD, SIGNIA (PER SITE REPORTER). ISSUED RGA# [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319606 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN SIGTRSB60AMT N4A2014Y

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown