BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3706335 · Received March 27, 2014

    Report

    Report Number
    2955842-2014-01823
    Event Type
    Other
    Date Received
    March 27, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HIGH RESOLUTION STEREO VIEWER (HRSV) INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER'S REPORTED ISSUE. THERE WAS NO VISION IN THE LEFT VIEWER. THE IMAGE ON THE RIGHT VIEWER WAS NORMAL. THERE WERE NO ISSUES FOUND WITH THE DVI CABLE CONNECTOR. ALL MIRRORS OF THE HRSV WERE FOUND TO BE IN GOOD CONDITION. THE INSULATION AROUND BOTH LENSES WAS DAMAGED. A MINOR SCRATCH OUTSIDE OF THE INSULATION OF THE LEFT FAN CABLE WAS OBSERVED. HOWEVER, THE FAN WAS STILL WORKING PROPERLY.

    Additional Manufacturer Narrative · 1

    THE HRSV HAS NOT BEEN RETURNED BACK TO ISI FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DUE TO THE ALLEGED ISSUE WITH THE LEFT HRSV, THE SURGEON DECIDED TO ABORT THE DA VINCI PROCEDURE POST ANESTHESIA. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THERE WAS NO IMAGE ON THE LEFT HIGH RESOLUTION STEREO VIEWER (HRSV). THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE SITE RESTART AND EMERGENCY POWER OFF (EPO) THE DA VINCI SURGICAL SYSTEM, HOWEVER, THE REPORTED ISSUE PERSISTED. THE TSE CHECKED THE IMAGE ON THE ASSISTANT MONITOR AND NOTICED THAT THE LEFT MONITOR WAS BLACK THE ENTIRE TIME, WHILE THERE WERE NO ISSUES WITH THE RIGHT MONITOR. DUE TO THE ALLEGED ISSUE, THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI PROCEDURE POST ANESTHESIA. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE EVENT AT THIS TIME. ON (B)(4) 2014, THE ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE REPAIRED THE SYSTEM BY REPLACING THE HRSV. THE FSE TESTED THE DA VINCI SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179995 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other