BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-LOC 180 E STITCH AND 0 6 LOOP

    MDR report key: 3080680 · Received April 11, 2013

    Report

    Report Number
    3080680
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 14, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: THE PT WAS BROUGHT TO THE OPERATING ROOM FOR A TOTAL LAPAROSCOPIC HYSTERECTOMY. UPON SUTURING, THE PHYSICIAN WAS USING THE ENDOSTITCH WITH V-LOC SUTURE. THE SUTURE BROKE OFF THE APPARATUS. THE END OF IT WAS THEN CUT AND REMOVED. SUTURING CONTINUED. AFTER THE SUBCUTANEOUS LAYER WAS SUTURED, IT WAS NOTED THAT THE END OF THE V-LOC SUTURE WAS MISSING. ALL SUTURES WERE UNDONE AND THE PT AND ENVIRONMENT WERE THOROUGHLY SEARCHED. SUTURING WAS RE-DONE WHEN IT WAS DETERMINED SUTURE WAS NOT RETAINED. PLEASE REF MFR REPORT # 1219930-2013-00262.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155572 V-LOC 180 E STITCH AND 0 6 LOOP VLOC KOG COVIDIEN, FORMERLY US SURGICAL N2G0596UX

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other LOT N2H0423X, MFR DATE 07/2012,| EXP DATE: 07/31/2015, (B)(4)| ENDOSTITCH 10MM SUTURING DEVICE, (B)(4)