BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER SURGICAL PLATFORM

    MDR report key: 2773405 · Received September 28, 2012

    Report

    Report Number
    3007593944-2012-00006
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    TRANSENTERIX INC.
    Product Code
    OTJ
    PMA / PMN Number
    K102839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE SURGEON REPORTED A LOSS OF RESPONSIVENESS WITH THE DEVICE DUE TO A DISLODGED GIMBAL AND LOOSE WIRE. THE UNIT WAS RETURNED AND DURING THE EVAL OF THE UNIT IT WAS DETERMINED THAT THE WIRE HAD BROKEN. NO INJURY OR IMPACT TO PT CARE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER SURGICAL PLATFORM OTJ, LAPAROSCOPIC SINGLE PORT ACCESS OTJ TRANSENTERIX INC. 9000020 G2L TX079121

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK