BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3827485 · Received May 22, 2014

    Report

    Report Number
    2955842-2014-03146
    Event Type
    Other
    Date Received
    May 22, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSM 1 WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. EVALUATION WAS ABLE TO DUPLICATE THE ISSUE EXPERIENCED BY THE SITE. THE AXIS 3 BRAKE ON THE PSM WOULD NOT DISENGAGE WHEN IT WAS ENERGIZED AND AS A RESULT DURING FUNCTIONAL TESTING OF THE PSM IT WOULD NOT INITIALIZE. 24 VOLTS WERE SUPPLIED TO THE BRAKE 3 ON THE PSM AND IT STILL DID NOT DISENGAGE. AFTER AN IN-HOUSE TEST BRAKE WAS INSTALLED TO THE HARNESS AND THE HARNESS WAS CONNECTED TO AN IN-HOUSE BRAKE BOX AND 24 VOLTS WERE SUPPLIED, THE AXIS 3 BRAKE DISENGAGED. THE AXIS 3 BRAKE WAS REPLACED TO REPAIR THE PSM. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES AFTER HE WAS UNABLE PROCEED WITH THE PROCEDURE UTILIZING PSM 1 DUE TO AN ISSUE WITH THE PSM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SIGMOID COLECTOMY PROCEDURE, DURING CHANGING OF AN ENDOWRIST INSTRUMENT, THE PATIENT SIDE MANIPULATOR (PSM) 1 REMAINED GREEN AND WOULD NOT GO TO READY. THE SITE UNDOCKED THE SYSTEM FROM THE PATIENT AND POWER CYCLED THE SYSTEM AND THE SITE EXPERIENCED THE ERROR MESSAGE ARM 1 WAS NOT FREE TO MOVE. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ASSISTANCE. WITH THE ASSISTANCE OF A TECHNICAL SUPPORT ENGINEER (TSE) THE SITE PERFORMED A BACK DRIVE OF ALL AXES; HOWEVER, THE ISSUE RECURRED. THE SITE INDICATED TO THE TSE THAT THEY WERE ABLE TO UTILIZE PSM 2 AND PSM 3; HOWEVER, PSM 1 WOULD NOT HOME. THE SURGEON INDICATED THAT HE DID NOT WANT TO USE PSM 3 IN PLACE OF PSM 1 AND MADE THE DECISION TO COMPLETE THE SURGICAL TASK USING OPEN SURGICAL TECHNIQUES. ON (B)(4) 2014, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR. ACCORDING TO THE ROBOTICS COORDINATOR, THE ISSUE WITH THE PSM OCCURRED APPROXIMATELY 22 MINUTES INTO THE SURGICAL PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE ISSUE WITH THE SYSTEM AND THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE COMPLICATIONS DURING THE OPEN PROCEDURE. THE ROBOTICS COORDINATOR INDICATED THAT TO THE BEST OF HIS KNOWLEDGE, THE PATIENT DID NOT EXPERIENCE ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. ON (B)(4) 2014 AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE CONCLUDED THAT THE ISSUE EXPERIENCED BY THE SITE WAS ASSOCIATED WITH PSM 1. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305828 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other