BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3107932 · Received May 10, 2013

    Report

    Report Number
    2955842-2013-01635
    Event Type
    Other
    Date Received
    May 10, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION PERFORMED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT THE SYSTEM ISSUE EXPERIENCED BY THE SITE WAS ASSOCIATED WAS ASSOCIATED WITH THE PATIENT SIDE CART MEDICAL GRADE POWER SUPPLY (MGPS). THE MGPS CONVERTS THE AC POWER FROM THE WALL SOCKET (THROUGH THE POWER CORD) AND CONVERTS IT TO DC POWER FOR USE ON THE SYSTEM. THE MGPS WAS REPLACED TO REPAIR THE SYSTEM. THE MGPS WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING REPLICATED THE FAILURE MODE EXPERIENCED BY THE SITE. THE MGPS WAS INSTALLED ON AN INTUITIVE SURGICAL, INC. (ISI) IN-HOUSE SURGEON SIDE CART (SSC). THE SSC DID NOT POWER ON WITH THE MGPS INSTALLED. A VISUAL INSPECTION OF THE MGPS FOUND THAT IT WAS IN GOOD CONDITION. AS OF (B)(6) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THIS FAILURE MODE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI PROSTATECTOMY PROCEDURE, WHEN THE SITE POWERED ON THE SYSTEM, THE SURGEON SIDE CART (SSC) LOST POWER. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE WAS ON-SITE WHEN THE SITE EXPERIENCED THE POWER ISSUE. THE CSR ATTEMPTED TO POWER ON THE SSC; HOWEVER, THE ISSUE RECURRED. THE SURGEON ABORTED THE PLANNED SURGICAL PROCEDURE AND RE-SCHEDULED IT FOR A LATER DATE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208946 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SURG SYS, INSTRUMENTS AND ACCESSORIES