BEUDAMED
    FDA Adverse Event Injury Summary report: N

    173016 @ENDO STITCH 10 MM SUTURING D

    MDR report key: 21841262 · Received April 15, 2025

    Report

    Report Number
    3032391-2025-00003
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 15, 2025
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    HCF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT "ONCE IT IS LOADED AND LOCKED, WHEN THEY GET INSIDE, THE ENDOSTITCH DOES NOT HOLD THE STITCH, IT FALLS INTO THE PATIENT'S BODY CAVITY". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ENDOSTITCH DOES NOT HOLD THE STITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103854 173016 @ENDO STITCH 10 MM SUTURING D HCF MEDLINE RENEWAL 520370, 520371, 520945, 520982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other