BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER FLEXIBLE GRASPER

    MDR report key: 2407377 · Received December 9, 2011

    Report

    Report Number
    3007593944-2011-00009
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    November 11, 2011
    Report Date
    December 9, 2011
    Manufacturer
    TRANSENTERIX, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K091697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JAWS HAVE BEEN VISUALLY EVALUATED. THEY ARE MANUFACTURED BY METAL INJECTION MOLDING. IT IS BELIEVED THAT THE METAL MAY HAVE HAD A DEFECT SUCH AS POROSITY. THE SAMPLE IS BEING SENT TO A METALLURGICAL LAB FOR EVALUATION. THERE HAS BEEN ONE OTHER RELATED FAILURE SINCE THE PRODUCT HAS BEEN IN DISTRIBUTION AND THIS IS THE SECOND INCIDENT OF THIS TYPE. THE PRODUCT HAS BEEN IN DISTRIBUTION OVER 21 MONTHS.

    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 DSC102201002R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK