BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENDO GIA ROTICULATOR 30-2.5 SULI

    MDR report key: 3833444 · Received May 20, 2014

    Report

    Report Number
    1219930-2014-00386
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    GAG
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP. CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: AT SET UP OF DUCTUS CYSTICUS (WAS INFLAMMATORY THICKENED CHRONICALLY), STAPLES COULD NOT CORRECTLY OR COMPLETELY FIRED. THE SURGERY HAD TO BE EXTENDED OF MORE THAN 30 MINUTES. SURGERY HAD TO BE CONVERTED TO OPEN. THE INCISION HAD TO BE EXTENDED. THERE WAS NO BLOOD LOS. THERE WAS NO TISSUE DAMAGE OR TISSUE LOSS. BILE DUCT REVISION BILIODIGESTIVE ANASTOMOSE HAD TO BE PERFORMED. THERE WERE NO POST SURGERY COMPLICATIONS. THE PT LEFT HOSPITAL WITH WELL OVERALL STATUS. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298955 CENDO GIA ROTICULATOR 30-2.5 SULI REUSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY US N3K0398LX

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention ENDO GIA UNIVERSAL 12MM SINGLE USE INST,| CATALOG#030449, K900129.