BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTICULATOR 30-V3 TITANIUM STAPLER

    MDR report key: 1133386 · Received August 22, 2008

    Report

    Report Number
    2647580-2008-00485
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 18, 2008
    Report Date
    August 14, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K855047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: NEPHRECTOMY. ACCORDING TO THE REPORTER: THE INSTRUMENT JAMMED AND LOCKED ON TISSUE. IT TOOK MORE TIME TO RELEASE THE INSTRUMENT FROM THE TISSUE THAT LED TO AN INCREASE IN SURGERY TIME. SUTURING WAS DONE TO RESOLVE THE ISSUE AFTER MORE THAN 30 MINUTES. THE PATIENT IS IN GOOD CONDITION. NO FURTHER ISSUE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR 30-V3 TITANIUM STAPLER SURGICAL STAPLER GDW PONCE - USS P7J0775

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention