BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM MF TA* 30-V3 TITANIUM STAPLER

    MDR report key: 6096464 · Received November 11, 2016

    Report

    Report Number
    1219930-2016-01182
    Event Type
    Injury
    Date Received
    November 11, 2016
    Report Date
    October 19, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    FHM
    PMA / PMN Number
    K801589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE PREMIUM MF TA 30-V3 TITANIUM STAPLER AND TWO PREMIUM MF TA 30-V3 TITANIUM DLU . THIS EVALUATION WAS BASED ON A MEDICAL AND TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS AND AN EVALUATION OF THE RETURNED DEVICE. THE JAWS WERE OPEN. THE SULUS WERE FULLY FIRED; ONE SULU HAD TWO MALFORMED STAPLE. THE SULUS WERE RELOADED WITH STAPLES. THE INSTRUMENT AND SULUS WERE FIRED OVER TEST MEDIA WITH ACCEPTABLE STAPLE FORMATION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A THORACIC PROCEDURE, THE DOCTOR ATTEMPTED TO FIRE THE DEVICE ON 2 OCCASIONS RESULTING IN BLEEDING. STAPLER DEPLOYMENT WAS INCOMPLETE, RESULTING IN ONLY PARTIAL LIGATION OF THE PULMONARY VEIN. THE DOCTOR SUBSEQUENTLY LIGATED THE REMAINDER OF THE PULMONARY VEIN WITH PROLENE SUTURE TO ACHIEVE HEMOSTASIS. THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748869 PREMIUM MF TA* 30-V3 TITANIUM STAPLER APPARATUS, SUTURING, STOMACH AND INTESTINAL FHM COVIDIEN, FORMERLY US SURGICAL A DIVISON 010315 N4F0438X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention