BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - SINGLE PORT SURGICAL DEVICE

    MDR report key: 1853678 · Received September 8, 2010

    Report

    Report Number
    3007593944-2010-00012
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 9, 2010
    Report Date
    September 13, 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 PATIENT LAP-BANDING PROCEDURE, THE SURGEON NOTICED THAT THE LEFT INSTRUMENT DELIVERY TUBE ON THE SPIDER DEVICE WAS NOT FUNCTIONING PROPERLY. AT END OF CASE, SURGEON SAW THROUGH THE ENDOSCOPE THAT LINK ARM DETACHED. UPON RETRIEVAL OF SPIDER, SURGEON NOTED THREE BROKEN PIECES. SURGEON RETRIEVED ALL BROKEN PARTS. NO INJURY OR IMPACT TO PATIENT CARE WAS REPORTED. THE DEVICE WAS RETURNED TO TRANSENTERIX, 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. 900020 TRX169201002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK