BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER FLEXIBLE GRASPER

    MDR report key: 2481066 · Received March 2, 2012

    Report

    Report Number
    3007593944-2012-00002
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    January 18, 2012
    Report Date
    March 2, 2012
    Manufacturer
    TRANSENTERIX, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K091697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE JAW FROM A FLEXIBLE GRASPER BROKE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN JAW FROM THE ABDOMINAL SPACE. NO INJURY OR IMPACT TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER FLEXIBLE GRASPER GCJ, LAPAROSCOPIC INSTRUMENT/ACCESSORY GCJ TRANSENTERIX, INC. 9000027 DC210112

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK