BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - SINGLE PORT SURGICAL DEVICE

    MDR report key: 1699039 · Received May 20, 2010

    Report

    Report Number
    3007593944-2010-00001
    Event Type
    Malfunction
    Date Received
    May 20, 2010
    Date of Event
    April 20, 2010
    Report Date
    April 20, 2010
    Manufacturer
    TRANSENTERIX INC.
    Product Code
    GCJ
    PMA / PMN Number
    K090902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A PT CHOLECYSTECTOMY PROCEDURE, THE SURGEON REPORTED THAT THE SPIDER INSTRUMENT DELIVERY TUBE (IDT) FUNCTIONALITY, I.E. ABILITY TO MOVE UP AND DOWN, WAS LIMITED. THE SURGEON COMPLETED THE PROCEDURE WITH THE SPIDER INSTRUMENT. NO INJURY OR IMPACT TO PT CARE WAS REPORTED. THE DEVICE WAS RETURNED TO TRANSENTERIX, INC FOR EVAL. AT THE TIME THAT TRANSENTERIX VISUALLY INSPECTED THE DEVICE AS PART OF THE COMPLAINT INVESTIGATION, IT WAS NOTED THAT A RIVET HAD SEPARATED FROM THE PLASTIC CONNECTOR. TWO SMALL PORTIONS OF PLASTIC FROM THE CONNECTOR WERE MISSING FROM THE RETURNED PRODUCT; THE VOLUME OF THE TWO MISSING PIECES WAS APPROXIMATELY 0.005 MM3 AND 0.015 MM3. THE PIECES COULD NOT BE LOCATED IN THE BAG IN WHICH THE INSTRUMENT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER - SINGLE PORT SURGICAL DEVICE GCJ TRANSENTERIX INC. 9000020 TRX085201001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK