BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - SINGLE PORT SURGICAL DEVICE

    MDR report key: 1781109 · Received July 29, 2010

    Report

    Report Number
    3007593944-2010-00005
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 28, 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 INTRODUCER SHEATH (SHEATH) WOULD NOT ADVANCE OVER THE INSTRUMENT DELIVERY TUBES (IDT) AND THE DEVICE COULD NOT BE RETRACTED. THE INCISION WAS ENLARGED TO FACILITATE REMOVAL OF THE SPIDER DEVICE. NO INJURY OR IMPACT TO PT CARE WAS REPORTED. THE DEVICE WAS NOT RETURNED TO TRANENTERIX, INC. FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER - SINGLE PORT SURGICAL DEVICE LAPAROSCOPIC, GENERAL & PLASTIC GCJ TRANSENTERIX INC. 9000020 TRX099201002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK