BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VLOC 180 ESTITCH ABS 0 8 LOOP

    MDR report key: 3843659 · Received May 27, 2014

    Report

    Report Number
    1219930-2014-00404
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GAM
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HYSTERECTOMY. ACCORDING TO THE REPORTER: AFTER DIFFICULTY LOADING THE DEVICE, THE SURGEON DECIDED TO HAND LOAD THE NEEDLE. THE INCIDENT OCCURRED AFTER THE THIRD BITE INTO FULL THICKNESS TISSUE (SECOND LAYER CLOSURE OF THE VAULT) USING THE HAND LOADED NEEDLE. AS THE SURGEON WAS WIGGLING THE TISSUE FROM THE JAWS OF THE DEVICE POST SUTURING THE TISSUE, THE NEEDLE BROKE. TWO-THIRDS OF THE NEEDLE STAYED IN THE JAWS OF THE DEVICE BUT THE OTHER 1/3 PART OF THE NEEDLE EMBEDDED INTO THE ABDOMINAL WALL BELOW BETWEEN THE UMBILICUS AND THE PELVIC FLOOR. AN X-RAY SHOWED THE NEEDLE WAS IN THE ABDOMINAL WALL BUT AFTER ALMOST 1 HOUR OF SEARCHING AND REPEATING THE X-RAY, THE NEEDLE STILL COULD NOT BE LOCATED. THE SURGEON ALSO TRIED USING A MAGNET TO FIND THE NEEDLE BUT THIS TOO WAS UNSUCCESSFUL. THE PATIENT WAS UNDER ANAESTHESIA FOR ONE AND A HALF HOURS EXTRA TO THE NORMAL PROCEDURE TIME AND THE BROKEN PART OF THE NEEDLE WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311819 VLOC 180 ESTITCH ABS 0 8 LOOP DISPOSABLE SUTURING DEVICE GAM COVIDIEN, FORMERLY US SUR N3A0231X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other