BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2939813 · Received February 1, 2013

    Report

    Report Number
    2955842-2013-00334
    Event Type
    Other
    Date Received
    February 1, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE. FUNCTIONAL TESTING OF THE 2 PATIENT SIDE MANIPULATOR (PSM) ARM IN CONJUNCTION WITH THE STERILE ADAPTER USED DURING THE SURGICAL PROCEDURE FOUND NO ISSUES WITH THE STERILE ADAPTER. FUNCTIONAL TESTING OF THE LEFT MASTER TOOL MANIPULATOR (MTM) IN CONJUNCTION WITH THE PSM FOUND THAT THE LEFT MTM FUNCTIONED PROPERLY. INSPECTION OF THE PSM'S CABLE TENSIONS AND INTERNAL GEARS FOUND THAT THEY WERE ALSO WITHIN SPECIFICATION. THE PATIENT SIDE MANIPULATOR IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART, WHICH PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). THE STERILE ADAPTER PROVIDES THE ISOLATION BARRIERS TO ELECTRICAL CURRENT. WHILE THE FSE WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE, PSM 3 AND PSM 4 WERE SWAPPED AND THE LEFT MTM WAS RE-CALIBRATED AS A PRECAUTION. A SINE CYCLE PERFORMED ON PSM 2, PSM 3, PSM 4 AND THE LEFT MTM FOUND THAT THE SITE'S DA VINCI S SURGICAL SYSTEM FUNCTIONED WITHIN SPECIFICATION. A SINE CYCLE IS A TEST PROCEDURE IN WHICH THE PSM ARM IS AUTOMATICALLY DRIVEN BACK AND FORTH REPEATEDLY WHILE MONITORING SENSOR DATA AND ERROR STATES. ON (B)(6) 2013 ISI CONTACTED THE INITIAL REPORTER OF THIS INCIDENT. THE INITIAL REPORTER INDICATED THAT THE SURGEON'S DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES WAS DUE TO A DIFFICULT PATIENT ANATOMY AND THE ARTICULATION ISSUE EXPERIENCED BY THE SURGEON. THE INITIAL REPORTER INDICATED THAT THE PATIENT TOLERATED THE OPEN PROCEDURE WELL, THERE WAS NO HARM TO THE PATIENT AND THE PATIENT DID NOT EXPERIENCE ANY SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. AS OF (B)(6) 2013, 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 S HYSTERECTOMY PROCEDURE, THE SURGEON EXPERIENCED ARTICULATION ISSUES WHILE MANIPULATING AN INSTRUMENT INSTALLED ON THE 2 PATIENT SIDE MANIPULATOR (PSM) ARM. THE SITE CONTACTED ISI FOR TECHNICAL SUPPORT ASSISTANCE. THE SITE INDICATED TO THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY RESEATED THE STERILE ADAPTER; HOWEVER, THE ISSUE PERSISTED. PRIOR TO CONTACTING ISI FOR TECHNICAL SUPPORT ASSISTANCE, THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43878 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS 2000 A51.P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE