BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 2901680 · Received January 2, 2013

    Report

    Report Number
    1219930-2012-01048
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 7, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON: (B)(4) 2012.

    Description of Event or Problem · 1

    PROCEDURE: THORACOSCOPY. ACCORDING TO THE REPORTER: THERE WAS A MAJOR ISSUE WITH THE STAPLING WHICH DID NOT WORK AT ALL SO THE SURGEON HAD TO CONVERT TO A THORACOTOMY IN EMERGENCY TO MAKE THE HEMOSTASIS. THE PATIENT LOST OVER 1 LITER OF BLOOD. FURTHER INFORMATION: THE DEVICE DID NOT STAPLE AFTER FIRING THE FIRST HALF OF THE SULU. THE INCIDENT HAPPENED IN THE MIDDLE OF THE SECOND HALF OF THE SULU. EVERYTHING STARTED FINE BUT THEN THERE WAS LIKE A RESISTANCE AND A CRACKLING NOISE, THE STAPLE SHUT BUT NO STAPLES CAME OUT. THERE WAS NO DIFFICULTIES IN FITTING THE SULU IN THE FIRST PLACE. WAS THERE ANY UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM? YES, PULMONARY TEAR. WAS THERE ANY TISSUE DAMAGED AS RESULT OF THIS PROBLEM? IF YES, DESCRIBE THE DAMAGE AND PROVIDE DETAILS ON HOW THE DAMAGE WAS TREATED/CORRECTED. WAS THE DAMAGE REVERSIBLE? YES, PULMONARY TEAR. WAS THERE BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM? YES, OVER 1 LITRE. DID ANY ADDITIONAL BLOOD LOSS RESULTING FROM THIS PRODUCT PROBLEM REQUIRE A BLOOD TRANSFUSION? YES, 1 "CULOT". WAS SURGICAL TIME EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM? YES. WAS ANY ADVERSE EVENT REPORTED AS A RESULT OF ANY DELAY IN SURGERY? (I.E. AN EXTENSION OF THE HOSPITAL STAY, INFECTION, ETC?) THE PATIENT STAYED 48 HOURS LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW COVIDIEN, FORMERLY US SURGICAL N2C0785X

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R LOTN2A040LX| ENDO GIA ROTICULATOR 45-3.5 SULU, 030455,| MFR 01/2012, EXP 01/31/2017