BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTICULATOR 55 POLY*-.170 STAPLER

    MDR report key: 3901529 · Received June 23, 2014

    Report

    Report Number
    1219930-2014-00467
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 20, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GAG
    PMA / PMN Number
    K830199
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: POLYABSORBABLE STAPLES DID NOT DEPLOY PROPERLY. THE SURGEON CUT THE TISSUE. SURGEON HAND-SEWED CUFF. NO EXCESS BLOOD LOSS; CUFF CLOSED WITH SUTURE. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED EXTENSION FOR THE INCISION MORE THAN ONCE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS NO DELAY OVER 30 MINUTES. NO DEVICE FRAGMENT FELL IN THE PATIENT CAVITY. NO DEVICE FRAGMENT WAS LEFT IN THE PATIENT. NO OTHER MANUFACTURER REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365772 ROTICULATOR 55 POLY*-.170 STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N2L0388X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other