BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4045753 · Received August 28, 2014

    Report

    Report Number
    2955842-2014-05309
    Event Type
    Other
    Date Received
    August 28, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    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 CAMERA HEAD WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED FAILURE MODE WAS CONFIRMED WITH THE EVALUATION OF THE CAMERA HEAD. THE CAMERA HEAD WAS FOUND TO HAVE A DAMAGED STAGE ASSEMBLY. THE CAMERA HEAD WAS OUT OF ALIGNMENT AND NEEDED ADJUSTMENT. THE FIBER OPTIC CABLE WAS ALSO FOUND TO BE DAMAGED AND NEEDED REPLACEMENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING A VISION ISSUE WITH THE DA VINCI SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, THE SURGICAL STAFF COULD NOT GET THE CAMERA TO FOCUS. DURING THE EVENT, THE SURGICAL STAFF CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. THE TSE WAS UNABLE TO RESOLVE THE REPORTED ISSUE WITH TROUBLESHOOTING OF THE CAMERA. THE SURGICAL STAFF DID NOT HAVE A BACKUP CAMERA HEAD FOR TROUBLESHOOTING. THE SITE WAS SENT A REPLACEMENT CAMERA HEAD. ON (B)(4) 2014, ISI CONTACTED A NURSE FROM THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE NURSE, THE PATIENT WAS UNDER ANESTHESIA WHEN THE CAMERA ISSUE WAS OBSERVED AND NO INCISION PORTS HAD BEEN PLACED AT THE TIME. DUE TO THE REPORTED VISION/CAMERA ISSUE, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES. THE NURSE INDICATED THAT THE OPEN SURGERY WAS COMPLETED SUCCESSFULLY AND NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. ON (B)(4) 2014, AN ISI FIELD SERVICE ENGINEER (FSE) CONTACTED THE SITE. THE SITE INFORMED THE FSE THAT THE DA VINCI SURGICAL SYSTEM WAS WORKING PROPERLY WITH A NEW CAMERA HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524475 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

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