BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER - FLEX MONOPOLAR HOOK

    MDR report key: 1814750 · Received August 13, 2010

    Report

    Report Number
    3007593944-2010-00007
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 13, 2010
    Manufacturer
    TRANSENTERIX INC.
    Product Code
    GCJ
    PMA / PMN Number
    K091697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A MINIMALLY INVASIVE ABDOMINAL LAPAROSCOPIC SURGERY, THE SURGEON REPORTED THAT THE SPIDER FLEX MONOPOLAR HOOK INSTRUMENT DELIVERED A CHARGE TO HIS RIGHT GLOVE INDEX FINGER WHILE HE WAS TOUCHING THE INSTRUMENT SHAFT. NO INJURY OR IMPACT TO SURGEON OR PATIENT CARE WAS REPORTED. THE SURGEON USED TO DEVICE TO COMPLETE THE SURGERY AND RETURNED TO TRANSENTERIX, INC. FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER - FLEX MONOPOLAR HOOK LAPAROSCOPIC, GENERAL & PLASTIC SURGERY GCJ TRANSENTERIX INC. 9000031 DSC180201002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK