BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER SURGICAL PLATFORM

    MDR report key: 2613392 · Received June 8, 2012

    Report

    Report Number
    3007593944-2012-00005
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Date of Event
    April 7, 2012
    Report Date
    June 8, 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 LOOSE WIRE. THE UNIT WAS RETURNED 30 DAYS AFTER THE EVENT WAS REPORTED AND DURING THE EVALUATION OF THE UNIT, IT WAS DETERMINED THAT THE WIRE HAD BROKEN. NO INJURY OR IMPACT TO PATIENT 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 TX017121

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK