BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 2031568 · Received March 25, 2011

    Report

    Report Number
    2031568
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 22, 2011
    Manufacturer
    COVIDIEN VALLEYLAB, A DIVISION OF TYCO HEALTHCARE GRP LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, A (B)(6) WOMAN UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY. DURING SURGERY, THE INSULATING TIP ON A COVIDIEN LIGATURE DEVICE BROKE OFF OR CAME APART INSIDE THE PT'S ABDOMEN. THE SURGEON RETRIEVED THE PIECE, WITHOUT ANY APPARENT INJURY TO THE PT. THE SURGEON ALSO ORDERED AN ABDOMINAL X-RAY, WHICH WAS NEGATIVE, TO FURTHER ENSURE THAT THERE WAS NOT A RETAINED FOREIGN OBJECT. THE PIECE THAT CAME OFF IN THE ABDOMEN APPEARS TO BE A FLATTENED, SOFT, VERY THIN RUBBER TUBE ABOUT 2CM X .25C. DEVICE TAKEN OUT OF SERVICE AND REQUESTED FOR EVAL BY FDA IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE MONOPOLAR TIP LAPAROSCOPIC SEALER/DIVID GEI COVIDIEN VALLEYLAB, A DIVISION OF TYCO HEALTHCARE GRP LP LF5544 198496

    Patients

    Seq Age Sex Outcome Treatment
    1 Other