BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - SINGLE PORT SURGICAL DEVICE

    MDR report key: 2219842 · Received August 8, 2011

    Report

    Report Number
    3007593944-2011-00005
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    TRANSENTERIX INC.
    Product Code
    GCJ
    PMA / PMN Number
    K102839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE VIDEO TAKEN FROM THE LAPAROSCOPE WAS PROVIDED TO MFR AND REVIEWED. FROM THE VIDEO THE DAMAGE TO THE DEVICE COULD BE VISUALIZED AND THE APPROXIMATE POINT IN TIME IN WHICH THE DAMAGE OCCURRED WAS IDENTIFIED.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE TETHER WIRE HOLDING THE NOSE CONE BROKE. THE NOSE CONE AND PART OF THE TETHER WIRE DROPPED INTO THE SURGICAL SPACE AND WERE RETRIEVED BY THE SURGEON. INVESTIGATION IS NOT COMPLETE BUT IT APPEARS THAT THE WIRE MAY HAVE BEEN CUT OR DAMAGED DURING THE PROCEDURE. THE SURGEON WAS ABLE TO RETRIEVE THE NOSE CONE IN ABOUT 10 MINUTES. NO INJURY OR IMPACT TO PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER - SINGLE PORT SURGICAL DEVICE GCJ TRANSENTERIX INC. 9000020 G2L TX122111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK