BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - SINGLE PORT SURGICAL DEVICE

    MDR report key: 2019093 · Received February 8, 2011

    Report

    Report Number
    3007593944-2011-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 7, 2011
    Manufacturer
    TRANSENTERIX INC.
    Product Code
    GCJ
    PMA / PMN Number
    K090902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PATIENT LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON NOTED A SMALL STRAND OF PLASTIC PROTRUDING FROM THE DISTAL TIP OF THE RIGHT INSTRUMENT DELIVERY TUBE OF THE SPIDER INSTRUMENT. UPON INTRODUCTION OF A CLIP APPLIER, THE ITEM WAS PUSHED INTO THE SURGICAL BED. THE STRAND OF PLASTIC WAS THEN REMOVED FROM THE PATIENT WITHOUT INCIDENT BY THE SURGEON. ITEM APPEARS TO BE FROM A TORN LUMEN. THE SURGEON COMPLETED THE PROCEDURE WITH THE SPIDER INSTRUMENT. NO INJURY OR IMPACT TO PATIENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK