BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP* S-9.0 TITANIUM

    MDR report key: 4242420 · Received November 11, 2014

    Report

    Report Number
    2647580-2014-00966
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 30, 2014
    Report Date
    November 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    FZP
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT: WAS THE SURGEON ABLE TO SQUEEZE THE HANDLES? DESCRIBE WHAT ACTUALLY HAPPENED? THE CLIP LOADED AT 90 DEGREES. WHEN THE JAWS WERE CLOSED, THE CLIP LACERATED A BRANCH OF THE INTERNAL JUGULAR VEIN. THIS HAS HAPPENED AGAIN WITH ANOTHER APPLICATOR. DID THE CLIPS LOAD PROPERLY INTO THE JAWS? NO. DID THE CLIPS FORM CORRECTLY? YES, BUT AT 90 DEGREES TO THE DESIRED FORMATION. DID CLIPS FALL INTO THE PATIENT'S CAVITY? IF SO, HOW WERE THEY RETRIEVED? NO. WAS THERE ANY UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM? YES, THE IJV WAS LIGATED. WAS THERE ANY TISSUE DAMAGE AS A RESULT OF THIS PROBLEM? AS ABOVE. IF YES, DESCRIBE THE DAMAGE AND PROVIDE DETAILS ON HOW THE DAMAGE WAS TREATED/CORRECTED. THE IJV WAS LIGATED. WAS THE DAMAGE IRREVERSIBLE? YES. WAS THERE BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM? NO - THANKS TO THE SKILL OF THE SURGICAL TEAM. A) DID ANY ADDITIONAL BLOOD LOSS RESULTING FROM THIS PRODUCT PROBLEM REQUIRE A BLOOD TRANSFUSION? NO. WAS SURGICAL TIME EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM? NO - OUR RESPONSE TIME IS QUICKER THAN THAT WHEN THE IJV IS BLEEDING. WAS ANY ADVERSE EVENT REPORTED AS A RESULT OF ANY DELAY IN SURGERY? (I.E. AN EXTENSION OF THE HOSPITAL STAY, INFECTION, ETC.?) NO. WHAT IS THE PATIENT'S CURRENT STATUS? ALIVE AND WELL. HOW DID THE SURGEON CORRECT THE ISSUE? LIGATION OF IJV.

    Description of Event or Problem · 1

    PROCEDURE: THYROIDECTOMY. ACCORDING TO THE REPORTER: THE SURGEON REPORTED THE APPLICATOR HAD MISFIRED CAUSING TRAUMA TO THE JUGULAR VESSEL. THE SURGEON LIGATED THE VESSEL TO PREVENT FURTHER BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727477 PREMIUM SURGICLIP* S-9.0 TITANIUM DISPOSABLE CLIP APPLIER FZP COVIDIEN, FORMERLY USSC PUERTO RICO INC 134046 P4F0383X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other