BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3141033 · Received June 3, 2013

    Report

    Report Number
    2955842-2013-01947
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE ENDOSCOPE WAS RECEIVED WITH MECHANICAL DAMAGE TO THE PROXIMAL END RESULTING IN BROKEN OPTICAL COMPONENTS AND 3D OPTICAL MISALIGNMENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE THE LENS WAS NOTED TO BE MISSING ON THE ENDOSCOPE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244735 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A51.P8

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES