BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - FLEX MONOPOLAR HOOK

    MDR report key: 1781097 · Received July 29, 2010

    Report

    Report Number
    3007593944-2010-00004
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 28, 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

    DURING A MINIMALLY INVASIVE ABDOMINAL LAPAROSCOPIC SURGERY, THE SURGEON REPORTED THAT THE HOOK END EFFECTER OF THE SPIDER FLEX MONOPOLAR HOOK INSTRUMENT SEPARATED FROM THE INSTRUMENT FLEXIBLE SHAFT INTO THE SURGICAL BED. THE SURGEON WAS ABLE TO LOCATE AND RETRIEVE THE HOOK FROM THE PT WITHIN APPROX 5 MINUTES DURING THE PROCEDURE AND PRIOR TO CLOSURE. NO INJURY OR IMPACT TO PT CARE WAS REPORTED. THE DEVICE WAS RETURNED TO TRANSENTERIX, INC. FOR EVALUATION. DURING VISUAL INSPECTION AS PART OF THE COMPLAINT INVESTIGATION, IT WAS NOTED THAT THERE WAS DAMAGE TO THE INSULATION NEAR THE HOOK TIP. ALL OTHER COMPONENTS WERE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER - FLEX MONOPOLAR HOOK LAPAROSCOPIC, GENERAL & PLASTIC SURGERY GCJ TRANSENTERIX INC. 9000031 DSC079201001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK