BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER FLEX WAVY GRASPER

    MDR report key: 2310000 · Received September 30, 2011

    Report

    Report Number
    3007593944-2011-00007
    Event Type
    Malfunction
    Date Received
    September 30, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 30, 2011
    Manufacturer
    TRANSENTERIX INC.
    Product Code
    GCJ
    PMA / PMN Number
    K091697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GASTRIC BEND PROCEDURE, WHILE THE SURGEON WAS PULLING ON THE BAND TO LOCK IT INTO POSITION, THE LOWER JAW OF A FLEXIBLE GRASPER BROKE AND FELL INTO THE ABDOMINAL SPACE. THE SURGEON WAS SIMULTANEOUSLY PUSHING AGAINST THE BEND WITH A RIGID INSTRUMENT; IT IS NOT KNOWN WHETHER THE SURGEON MAY HAVE DAMAGED THE FLEXIBLE INSTRUMENT WHILE USING THE RIGID INSTRUMENT. THE SURGEON WAS ABLE TO RETRIEVE THE JAW AND ALL PARTS FROM THE INSTRUMENTS WERE ACCOUNTED FOR. NO INJURY OR IMPACT TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER FLEX WAVY GRASPER GCJ TRANSENTERIX INC. 9000026 DC122111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK