BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 4201876 · Received October 27, 2014

    Report

    Report Number
    9612501-2014-00378
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 10/27/2014.

    Description of Event or Problem · 1

    (B)(6). ACCORDING TO THE REPORTER: 2 NEEDLES DISLODGED FROM THE DEVICE DURING USE ((B)(4), LOT N4C1675X) NEEDLES DISLODGED WITHOUT PUSHING BLACK BUTTONS FORWARD. PRONGS (BUNNY EARS) WERE NOT EXTENDED AT TIME OF RELEASE. CURRENT PATIENT STATUS: STABLE. DID THE DIFFICULTY RESULT IN UNINTENDED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION ETC.: NO. UNANTICIPATED TISSUE LOSS? NO. HOW WAS THE DAMAGE TREATED/CORRECTED? SUTURE CUT AND VAGINAL CUFF CLOSURE STARTED WITH SECOND NEEDLE FROM THE SAME PREVIOUSLY MENTIONED VLOC RELOAD FROM THE SAME LOT AND CUFF CLOSURE COMPLETED. UNANTICIPATED EXTENSION OF THE INCISION BY MORE THAN ONE INCH? NO. UNANTICIPATED BLOOD LOSS OF 500CCS OR MORE? NO. WAS SURGICAL TIME DELAYED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM? NO. DEVICE FRAGMENT OR COMPONENT FALLING INTO THE PATIENTS CAVITY? NO. POST- OP DIAGNOSIS: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682377 ENDO STITCH* 10MM SUTURING DEVICE SINGLE USE SUTURING DEVICE KOG COVIDIEN 173016 J4F1548X

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR