BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - SURGICAL FLEX MONOPOLAR HOOK

    MDR report key: 1759437 · Received June 24, 2010

    Report

    Report Number
    3007593944-2010-00003
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 24, 2010
    Manufacturer
    TRANSENTERIX, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K091697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    JUST AFTER USE OF THE MONOPOLAR HOOK; TOWARDS THE END OF THE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON NOTED THAT THE HOOK TIP WAS POTENTIALLY MISSING FROM THE DEVICE. IT WAS DETERMINED THAT THE HOOK HAD SEPARATED FROM THE INSTRUMENT AND FALLEN INTO THE SURGICAL BED. THE SURGEON WAS ABLE TO LOCATE AND RETRIEVE THE HOOK FROM THE PATIENT PRIOR TO CLOSURE. NO INJURY OR IMPACT TO THE PATIENT WAS REPORTED. THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY 30 MINUTES. THE DEVICE WAS RETURNED TO TRANSENTERIX, INC FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED UNIT INDICATED THAT ALL OTHER COMPONENTS WERE PRESENT AND NO EVIDENCE OF INSULATION DEGRADATION OR FAILURE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER - SURGICAL FLEX MONOPOLAR HOOK GCJ TRANSENTERIX, INC. 9000031 DSC077201001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK