BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4399485 · Received January 8, 2015

    Report

    Report Number
    2955842-2015-00043
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 9, 2014
    Report Date
    January 5, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    2955842-020312-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SIDE MANIPULATOR (PSM) WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE PSM ARM FAILED THE WEIGHTED BRAKE DROP TEST. ISI HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS PSM AND DID NOT FIND ANY NON-CONFORMANCES THAT WERE RELATED TO THIS REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE PSM ARM FAILING THE WEIGHTED BRAKE DROP TEST DURING FAILURE ANALYSIS. NO PATIENT INVOLVEMENT OCCURRED, HOWEVER, IF THIS MALFUNCTION WERE TO RECUR IT COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS INITIALLY REPORTED TO INTUITIVE SURGICAL, INC. (ISI) FOR AN UNRELATED PROBLEM ASSOCIATED WITH THE PATIENT SIDE MANIPULATOR (PSM) EXPERIENCING MULTIPLE FAULTS ON ARM 1. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE PSM WAS REPLACED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ADVERSE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16067 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1