BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDO STITCH MEDTRONIC

    MDR report key: 17498082 · Received August 10, 2023

    Report

    Report Number
    MW5122854
    Event Type
    Other
    Date Received
    August 10, 2023
    Date of Event
    July 28, 2023
    Report Date
    August 4, 2023
    Manufacturer
    MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)
    Product Code
    OCW
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A LAPAROSCOPIC HYSTERECTOMY, SURGEON WAS INTERNALLY CLOSING THE CUFF OF THE VAGINA WITH THE ENDO STITCH (REF # (B)(4)), AND THE V-LOC SUTURE NEEDLE BROKE IN HALF WITH A PIECE OF NEEDLE WAS INSIDE OF PATIENT AND OTHER HALF WAS STILL INSIDE THE ENDOSTITCH. THE RETAINED PIECE OF NEEDLE WAS REMOVED FROM THE PATIENT. THE TWO PIECES OF THE NEEDLE WERE CONFIRMED TO BE THE WHOLE THING AFTER REMOVING. THE VLOC REF NUMBER IS (B)(4) AND LOT # IS N3C0057Y. REF REPORT: MW5122855.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784283 ENDO STITCH MEDTRONIC ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC) 173016

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown V-LOC SUTURE NEEDLE