BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3090851 · Received May 2, 2013

    Report

    Report Number
    2955842-2013-01515
    Event Type
    Other
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) CONCLUDED THAT THE VISION ISSUE EXPERIENCED BY THE SITE WAS ASSOCIATED WITH A FAULTY CAMERA CABLE. THE FSE SPOKE TO THE SITE'S ROBOTICS COORDINATOR AND THE ISI CLINICAL SALES REPRESENTATIVE (CSR). THEY INDICATED TO THE FSE THAT AFTER COMPLETION OF THE OPEN PROCEDURE, A BACKUP CAMERA CABLE WAS LOCATED AND AFTER REPLACEMENT OF THE FAULTY CAMERA CABLE THE VISION ISSUE WAS RESOLVED. ON (B)(4) 2013, THE ISI CLINICAL SALES REPRESENTATIVE, WHO WAS PRESENT DURING THE SURGICAL PROCEDURE, WAS CONTACTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR INDICATED THAT THE VISION ISSUE EXPERIENCED BY THE SITE OCCURRED AFTER THE PATIENT SIDE CART (PSC) WAS DOCKED TO THE PATIENT, THE INSTRUMENTS WERE INSTALLED AND AFTER THE SURGEON SAT DOWN AT THE SURGEON SIDE CART TO BEGIN THE SURGERY. THE SURGEON HAD NOT YET PERFORMED ANY SURGICAL TASKS. ACCORDING TO THE CSR, THE SURGICAL STAFF WAS NOT AWARE THAT THEIR BACKUP CAMERA CABLE WAS LOCATED IN THEIR MATERIALS DEPARTMENT WHEN THE VISION ISSUE OCCURRED AND THE PATIENT WAS UNDER ANESTHESIA FOR APPROXIMATELY 45 MINUTES WHEN THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES. THE CSR INDICATED THAT THERE WERE NO COMPLICATIONS EXPERIENCED BY THE PATIENT AND THAT THE PATIENT TOLERATED THE OPEN PROCEDURE WELL. PER THE CSR THE PATIENT DID NOT EXPERIENCE ANY POST-SURGICAL COMPLICATIONS AND THE PATIENT IS DOING OK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SACROCOLPOPEXY PROCEDURE, THE SURGEON EXPERIENCED A DARK AND DISTORTED RIGHT EYE IMAGE THROUGH THE HIGH RESOLUTION STEREO VIEWER (HRSV) ON THE SURGEON SIDE CART (SSC). THE SITE CONTACTED ISI FOR TECHNICAL SUPPORT ENGINEERING (TSE) ASSISTANCE. REVIEW OF THE SITE'S SYSTEM LOG BY THE TSE FOUND THAT THE SITE EXPERIENCED SYSTEM ERROR CODE 45310 AND THAT THE VISION ISSUE EXPERIENCED BY THE SITE WAS LIKELY DUE TO A FAULTY CAMERA CABLE. THE TSE INSTRUCTED THE SITE TO INSTALL A BACKUP CAMERA CABLE TO TROUBLESHOOT THE ISSUE; HOWEVER, THE SITE INDICATED THAT THEY DID NOT HAVE A BACKUP CAMERA CABLE AVAILABLE. THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192500 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60.P6

    Patients

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