BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER FLEX SUCTION IRRIGATION PROBE

    MDR report key: 2310012 · Received September 30, 2011

    Report

    Report Number
    3007593944-2011-00006
    Event Type
    Malfunction
    Date Received
    September 30, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 26, 2011
    Manufacturer
    TRANSENTERIX, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K091697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AT THE END OF A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DISTAL TIP OF A SUCTION IRRIGATOR INSTRUMENT FELL OFF INTO THE ABDOMINAL SPACE. THE INSTRUMENT HAD PRIMARILY BEEN USED TO IRRIGATE DURING THE PROCEDURE AND THERE WERE NO REPORTS OF UNUSUAL USE OR DAMAGE TO THE INSTRUMENT. THE SURGEON WAS ABLE TO RETRIEVE THE TIP AND ALL PARTS FROM THE INSTRUMENT WERE ACCOUNTED FOR. NO INJURY OR IMPACT TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER FLEX SUCTION IRRIGATION PROBE GCJ TRANSENTERIX, INC. 9000032 DSC099201001R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK