BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3453771 · Received November 6, 2013

    Report

    Report Number
    2955842-2013-05061
    Event Type
    Other
    Date Received
    November 6, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 7, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSC POWER SUPPLY WAS RETURNED TO ISI AND EVALUATED BY FAILURE ANALYSIS (FA). FA WAS ABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE BY INSTALLING THE UNIT INTO A PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM. INTUITIVE SURGICAL INC. (ISI) HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI SI INGUINAL HERNIA REPAIR PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING A PSC IS RUNNING ON BATTERY MESSAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI INGUINAL HERNIA REPAIR PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A MESSAGE INDICATING THAT THE PATIENT SIDE CART (PSC) WAS RUNNING ON BATTERY. THE SURGICAL STAFF CONTACTED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. THE SURGICAL STAFF VERIFIED THAT THE POWER CORD WAS SEATED FULLY ON THE BACK OF THE PSC AND THE ELECTRICAL WALL OUTLET. THE SURGICAL STAFF POWERED DOWN THE SYSTEM AND EMERGENCY POWERED OFF THE PSC. THE SURGICAL STAFF ALSO DISCONNECTED THE BLUE FIBER CABLE AND TRIED CYCLE POWERING THE PSC IN STAND ALONE MODE. THE REPORTED ISSUE PERSISTED. THE SURGICAL STAFF VERIFIED THAT THE ELECTRICAL OUTLET WAS FUNCTIONAL BY PLUGGING IN ANOTHER PIECE OF EQUIPMENT. DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES. ON OCTOBER 8, 2013, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE REPAIRED THE SYSTEM BY REPLACING THE POWER SUPPLY OF THE PSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571381 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES