BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 20255433 · Received September 19, 2024

    Report

    Report Number
    20255433
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 7, 2024
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SURGEON UNABLE TO ACTIVATE TRIGGER W/ FIBGER BECAUSE IT WAS TOO STIFF. REPORTED & RETURNED. RGA# [REDACTED]. FEDEX TRK# [REDACTED] [REDACTED]. MANUFACTURER RESPONSE FOR ENDO-STITCH SUTURE DEVISE, (BRAND NOT PROVIDED) (PER SITE REPORTER). ISSUED RGA# [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430987 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 173016 J4A312OEY

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female