BEUDAMED
    FDA Adverse Event Injury Summary report: N

    173016 @ENDO STITCH 10 MM SUTURING DEVIC

    MDR report key: 16280476 · Received February 1, 2023

    Report

    Report Number
    3032391-2023-00001
    Event Type
    Injury
    Date Received
    February 1, 2023
    Date of Event
    December 20, 2022
    Report Date
    March 15, 2023
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2022 THE ENDO STITCH NEEDLE BROKE INSIDE THE VAGINAL CUFF AND HAD TO BE RETRIEVED FROM THE PATIENT. PER THE FACILITY AN ADDITIONAL 20 MINUTES WAS ADDED TO THE CASE REQUIRING ADDITIONAL ANESTHESIA. NO ADDITIONAL INFORMATION WAS PROVIDED. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS RETURNED FOR EVALUATION, HOWEVER, THE REPORTED ISSUE WAS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2022 THE ENDO STITCH NEEDLE BROKE INSIDE THE VAGINAL CUFF AND HAD TO BE RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376525 173016 @ENDO STITCH 10 MM SUTURING DEVIC GAM MEDLINE RENEWAL 485663

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other