BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0 POLYSORB ENDOSTITCH

    MDR report key: 10658037 · Received October 8, 2020

    Report

    Report Number
    MW5097171
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    October 6, 2020
    Report Date
    October 6, 2020
    Manufacturer
    COVIDIEN
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE CLOSING THE VAGINAL CUFF WITH THE ENDOSTITCH SUTURING DEVICE WITH A 0 POLYSORB SUTURE (170050), THE NEEDLE BROKE IN 2 PIECES. ONE SECTION WAS REMOVED WITH ATTACHED SUTURE, THE OTHER SEGMENT WAS NOT FOUND. IMAGING WAS CALLED TO DO A/P AND LATERAL IMAGES . A TINY SPEC APPEARED ON FILM AND CONFIRMED IMAGE. ENDOSTITCH SUTURING DEVICE (173016), LOT#J9B0008EY, EXP 1/31/2024; 0 POLYSORB ENDOSTITCH (170056) LOT# J9M2542Y, EXP: 11/30/2024; LOT# J9D1628Y, EXP: 3/31/2024; LOT# J9C2540Y EXP: 2/29/2024. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118483 0 POLYSORB ENDOSTITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 170056 J9D1628Y
    1118484 0 POLYSORB ENDOSTITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 170056 J9C2540Y
    1118491 ENDOSTITCH SUTURING DEVICE ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 173016 J9B000EY
    1118492 0 POLYSORB ENDOSTITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN 170056 J9M2542Y

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention