BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIA

    MDR report key: 20245484 · Received September 18, 2024

    Report

    Report Number
    20245484
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 6, 2024
    Manufacturer
    COVIDIEN LP
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    STAPLE LOAD NOT FULLY CLOSING AFTER TESTING BEFORE PLACING INTO PORT, UNABLE TO USE STAPLE LOAD, UNABLE TO ADVANCE THROUGH PORT. PCT HAD NO PATIENT CONTACT. HAS BEEN REPORTED & RETURNED. RGA# [REDACTED], TRACKING # [REDACTED]. MANUFACTURER RESPONSE FOR STAPLE RELOAD, (BRAND NOT PROVIDED) (PER SITE REPORTER). ISSUED RGA# [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303120 GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP P3L0957

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female