BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO STITCH INSTRUMENT

    MDR report key: 2973967 · Received February 14, 2013

    Report

    Report Number
    1219930-2013-00097
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    October 3, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HYSTERECTOMY. ACCORDING TO THE REPORTER: (B)(6) WOMAN. THE PATIENT WAS THE IDEAL BODY TYPE FOR THIS PROCEDURE. SHE WAS NOT OVERWEIGHT, (B)(6) AND WAS IN FIT PHYSICAL CONDITION, LAPAROSCOPIC HYSTERECTOMY WITH TRANSVAGINAL MORCELLATION. DURING CLOSURE OF THE VAGINAL CUFF, THE ENDO STITCH NEEDLE BROKE. A PIECE WAS FOUND ON THE FLOOR BUT THE OTHER HALF WAS NOT LOCATED WITHIN THE PELVIS. AN X-RAY WAS COMPLETED WHICH IDENTIFIED A SMALL PIECE OF THE NEEDLE, THE SIZE OF A SURGICAL CLIP, LYING IN THE MID LOWER PELVIS, SLIGHTLY TO THE RIGHT. TWO SURGEONS INTERVIEWED: BOTH STATED THAT THESE NEEDLES CAN BREAK, BUT THIS OFTEN OCCURS WHEN THE PHYSICIAN MEETS RESISTANCE OR SOME OTHER DIFFICULTY. AND NORMALLY THE BROKEN PIECE STICKS IN THE TISSUE WHEN IT BREAKS. NEITHER HAD EXPERIENCED THIS TYPE OF BREAKAGE BEFORE. THE LITERATURE SUPPORTS THIS OBSERVATION. MOST BREAKS OCCUR FROM NEEDLE FATIGUE OR TRAUMA TO THE NEEDLE. YES, 1/2 OF THE NEEDLE FRAGMENT WAS RETRIEVED FROM THE PATIENT AND THE OTHER HALF WAS LOST ON THE FLOOR OF THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66183 UNKNOWN ENDO STITCH INSTRUMENT SURGICAL SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other