BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 3063464 · Received March 28, 2013

    Report

    Report Number
    1219930-2013-00212
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: DOCTOR PASSED JUST THE NEEDLE OF THE VLOC FOR ENDOSTITCH INTO THE TISSUE. THE TISSUE WAS TOO THICK. INSTEAD OF RETRIEVING IT BY PUSHING IT FORWARD, SHE TRIED TO PULL IT OUT FROM THE SUTURE END. A FEW BARBS FROM THE SUTURE WERE ALREADY IN THE TISSUE AS THE SUTURE BROKE UNDER TENSION LEAVING THE NEEDLE IN THE TISSUE. IT TOOK ABOUT 10 MINUTES TO RETRIEVE THE NEEDLE, BUT SHE FELT SHE MADE THAT TIME UP WITH THE SPEED ASSOCIATED USING ANOTHER VLOC FOR ENDOSTITCH ONCE THE NEEDLE WAS RETRIEVED. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THA 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129384 ENDO STITCH 10MM SUTURING DEVICE SURGICAL SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT # UNK, K934738| VLOCA208L: VLOC 180 ESTITCH ABS 2 0 8 LP,