BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 20255392 · Received September 19, 2024

    Report

    Report Number
    20255392
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    May 18, 2024
    Report Date
    June 7, 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

    SCRUB TECH NOTICED MULTIPLE STAPLE LOADS HAD LOOSE REINFORCEMENT, WHEN LOOKED AT MORE CLOSELY, GREEN SUTURE AT DISTAL TIP WAS MISSING. REPORTED & RETURNED. RGA# [REDACTED], FEDEX TRK# [REDACTED]. MANUFACTURER RESPONSE FOR STAPLE RELOADS, (BRAND NOT PROVIDED) (PER SITE REPORTER), ISSUED RGA# [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488134 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN SIGTRSB60AMT N4B1825Y

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female