BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER SURGICAL PLATFORM

    MDR report key: 3872743 · Received May 15, 2014

    Report

    Report Number
    3007593944-2014-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 26, 2014
    Report Date
    May 15, 2014
    Manufacturer
    TRANSENTERIX SURGICAL INC.
    Product Code
    GCJ
    PMA / PMN Number
    K102839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE SURGEON REPORTED A LOSS OF RESPONSIVENESS WITH THE DEVICE DUE TO LOOSE WIRES. THE UNIT WAS RETURNED TO THE MFR AND DURING THE PRELIMINARY EVALUATION OF THE UNIT, IT WAS DETERMINED THE WIRES HAD BROKEN. NO INJURY OR IMPACT TO PT CARE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289669 SPIDER SURGICAL PLATFORM LAPAROSCOPIC SINGLE PORT ACCESS GCJ TRANSENTERIX SURGICAL INC. 9000020 G2L TX200121

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK