BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTICULATOR 55-4.8 TITANIUM STAPLER

    MDR report key: 1924846 · Received December 8, 2010

    Report

    Report Number
    2647580-2010-00949
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 9, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K855047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLON RESECTION. ACCORDING TO THE REPORTER: THE STAPLES DID NOT FIRE AT ALL WHEN THE SURGEON FIRED THE DEVICE. THE SURGEON HAND SEWED THE STAPLE LINE. NO BLEEDING REPORTED. NO TISSUE DAMAGE REPORTED. IT WAS REPORTED THAT OPERATING ROOM TIME WAS DELAYED MORE THAN 30 MINUTES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR 55-4.8 TITANIUM STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO P0H0548

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R