BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN LLC ENDO STITCH AUTO SUTURE SUTURING

    MDR report key: 22167330 · Received June 9, 2025

    Report

    Report Number
    MW5171171
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    June 2, 2025
    Report Date
    June 6, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE SURGICAL CASE REQUIRED AN ENDOSTITCH DEVICE (REF (B)(4). THE DEVICE WAS OPENED TO THE BACK TABLE AND ASSESSED BEFORE USE BY THE SURGICAL TECH. THE DEVICE FAILED AND THE NEEDLE BROKE WHILE IN USE (LOT J4G2355EY). THE SURGICAL TECH CONFIRMED ALL PIECES WERE ACCOUNTED FOR AND ANOTHER ENDOSTITCH WAS REQUESTED. A SECOND ENDOSTITCH WAS OPENED (LOT J3F1603EY). THIS DEVICE WAS ASSESSED BEFORE USE AND ALSO BROKE DURING THE CASE; THE NEEDLE DID NOT TRANSFER FROM ONE WORKING END TO THE OTHER AND THE NEEDLE WAS DIFFICULT TO REMOVE. THE SURGICAL TECH CONFIRMED ALL PIECES WERE ACCOUNTED FOR AND A THIRD ENDOSTITCH WAS OPENED TO THE BACK TABLE. THE THIRD ENDOSTITCH WAS FUNCTIONAL AND WAS USED TO COMPLETE THE CASE. REFERENCE REPORT# MW5171172.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632097 COVIDIEN LLC ENDO STITCH AUTO SUTURE SUTURING SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN J4G2355EY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown