BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK

    MDR report key: 1872524 · Received October 8, 2010

    Report

    Report Number
    2647580-2010-00832
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 13, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GET
    PMA / PMN Number
    K914753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: TAP TRANSABDOMINAL PREPERITONEAL. ACCORDING TO THE REPORTER: THE DEVICE WAS INSERTED INTO CAVITY AND EXTENDED. THE SHAFT COATING PART BECAME EVERTED AND COULD NOT BE RETURNED TO ITS ORIGINAL POSITION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADDITIONAL BLEEDING, NOTHING FELL INTO THE PATIENT'S CAVITY, AND NO TISSUE DAMAGED. OPERATIVE TIME WAS NOT EXTENDED MORE THAN THIRTY MINUTES. NO PATIENT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO GRASP 5MM W/SPIN LOCK DISPOSABLE SURGICAL DEVICE GET USSC PUERTO RICO P0B0919

    Patients

    Seq Age Sex Outcome Treatment
    1