BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - SINGLE PORT SURGICAL DEVICE

    MDR report key: 1853679 · Received September 8, 2010

    Report

    Report Number
    3007593944-2010-00013
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 11, 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 ABDOMINAL LAPAROSCOPIC PROCEDURE, BOTH LOWER LINK ARMS DETACHED. MISSING PIECES OF INSERTION TUBE FITTING NOT ACCOUNTED FOR AFTER RETURN FROM HOSPITAL. 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 AND PLASTIC GCJ TRANSENTERIX INC. 9000020 TRX086201001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK