BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6115944 · Received November 20, 2016

    Report

    Report Number
    9612501-2016-00932
    Event Type
    Injury
    Date Received
    November 20, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 27, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE NEEDLE CAME OFF THE DEVICE AND THE SUTURE BROKE OFF THE NEEDLE. THE NEEDLE WAS LODGED BETWEEN TISSUES IN THE VAGINAL CUFF AND NOT VISIBLE. THE SURGEON HAD TO GO VAGINALLY TO RETRIEVE THE NEEDLE. NO X-RAY WAS NEEDED BUT IT EXTENDED THE CASE BY 45 MINUTES. AN INSTRUMENT WAS USED TO MANIPULATE THE TISSUE VAGINALLY AND ANOTHER INCISION WAS MADE UNTIL IT CAME OUT CAUSING TISSUE DAMAGE. THERE WAS ABOUT 25CCS OF UNANTICIPATED BLOOD LOSS. A SUTURE WAS USED TO REPAIR THE INCISION INTO THE VAGINA. A CYSTOSCOPY WAS PERFORMED TO CONFIRM NO BLADDER INJURY FROM THE VAGINA EXPLORATION. THE LAST KNOWN PATIENT STATUS IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766718 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention