BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1487679 · Received September 18, 2009

    Report

    Report Number
    2955842-2009-00312
    Event Type
    Other
    Date Received
    September 18, 2009
    Date of Event
    August 27, 2009
    Report Date
    August 27, 2009
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY ISI FIELD SERVICE ENGINEERING CONCLUDED THAT THE ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A PATIENT MANIPULATOR (PSM). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART AND PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE PSM WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING DISCOVERED THAT A PIECE OF THE CANNULA (LOCK/BEARING MECHANISM) HAD BROKEN OFF AND WAS RATTLING AROUND THE ELBOW AREA OF THE PSM. AS OF SEPTEMBER 17, 2009, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE CUSTOMER DETECTED A MECHANICAL PROBLEM WITH ONE OF THE SYSTEM ARMS. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| DA VINCI SURGICAL SYSTEM INSTRUMENTS