BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3092858 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01540
    Event Type
    Other
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM ERROR CODE 25580 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A REMOTE ARM CONTROLLER (RAC) PCA BOARD. THE RAC CONSISTS OF FIVE PRINTED CIRCUIT ASSEMBLY BOARDS (PCA) WHICH OPERATE TOGETHER TO PROVIDE CONTROL OF THE SYSTEM ARMS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED RAC PCA BOARD. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 25580 IS REPORTED WHEN THE DA VINCI SI SAFETY SYSTEM DETERMINES A HARDWARE FAULT REACTION LOGIC OCCURRED ON A LOCAL RAC. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DA VINCI IN A RECOVERABLE SAFE STATE. THE REMOTE ARM CONTROLLER (RAC) BOARD WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE. THE RAC PASSED FUNCTIONAL TESTING WITH NO ISSUES NOTED. ON (B)(4) 2013, ISI CONTACTED THE INITIAL REPORTER REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THERE WERE NO COMPLICATIONS EXPERIENCED BY THE PATIENT AS A RESULT OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF A DA VINCI SI PYELOPLASTY PROCEDURE, THE SURGICAL STAFF EXPERIENCED SYSTEM ERROR CODE 25580. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE) THE SITE POWERED OFF AND EMERGENCY POWERED ON THE SYSTEM MULTIPLE TIMES, HOWEVER, THE ISSUE PERSISTED. THE PATIENT WAS UNDER ANESTHESIA AND THE PORT PLACEMENTS WERE NOT YET CREATED WHEN THE SURGEON MADE THE DECISION TO ABORT THE PLANNED SURGICAL PROCEDURE AND RESCHEDULE IT FOR A LATER DATE. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195072 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60.P8

    Patients

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