BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTURATOR

    MDR report key: 3051473 · Received April 10, 2013

    Report

    Report Number
    2955842-2013-01191
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION CONDUCTED BY AN ISI FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE VISION ISSUE EXPERIENCED BY THE SITE WAS ASSOCIATED WITH THE PMVA PCA BOARD AND THE DIGITAL VIDEO INTERFACE (DVI) CABLE. THE PMVA IS A PRINTED CIRCUIT ASSEMBLY (PCA) WHICH RECEIVES THE STEREO VIDEO IMAGES FROM THE CAMERA CONTROLLER AND OUTPUTS THE AUDIO AND VIDEO FOR THE TOUCHSCREEN MONITOR. THE DVI CABLE CONNECTS THE VIDEO OUTPUT FROM THE PMVA TO THE TOUCHSCREEN MONITOR. REVIEW OF THE SITE'S SYSTEM LOG BY THE FSE FOUND NO SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PMVA PCA BOARD AND THE DVI CABLE. THE PMVA PCA BOARD WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION WAS ABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE, AS FUNCTIONAL TESTING OF THE PMVA PCA BOARD FOUND THAT THE FIBER PANEL LEAF (FPL) BOARD ON THE PMVA PCA BOARD WAS FAULTY. THE FPL WAS REPLACED TO REPAIR THE PMVA PCA BOARD. 62 - ON (B)(6) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS EVENT. THE CSR INDICATED THAT HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE; HOWEVER, HE WAS CONTACTED BY THE SURGICAL STAFF CONCERNING THE VISION ISSUE THAT OCCURRED DURING THE SURGICAL PROCEDURE. A PATIENT INJURY UNRELATED TO A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES HAD OCCURRED. THE CSR INDICATED THAT THE SURGICAL STAFF REPORTED THAT WHILE THE SURGEON WAS INSERTING A 5MM OBTURATOR THROUGH THE PATIENT'S BODY WALL, THE SURGEON INADVERTENTLY PUNCTURED THE PATIENT'S HEART, CAUSING THE SURGEON TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES TO REPAIR THE INJURY AND COMPLETE THE SURGICAL PROCEDURE. THE CSR INDICATED THAT BASED ON THE INFORMATION PROVIDED BY THE SURGICAL STAFF IT IS UNCLEAR IF THE DA VINCI SURGICAL SYSTEM WAS DOCKED TO THE PATIENT WHEN THE ISSUE OCCURRED. THE OBTURATOR WAS NOT RETURNED TO ISI FOR FAILURE ANALYSIS EVALUATION. ON (B)(4) 2013, ISI CONTACTED THE SURGEON'S OFFICE AND SPOKE TO THE SURGEON'S OFFICE ASSISTANT. THE SURGEON'S ASSISTANT INDICATED THAT BASED ON THE PATIENT'S OPERATIVE REPORT NOTES, THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) WAS DOCKED TO THE PATIENT WHEN THE OBTURATOR WAS INSERTED. THE SURGEON'S OFFICE ASSISTANT INDICATED THAT REPAIR TO THE PATIENT'S HEART WAS PERFORMED AND THAT SHE WAS UNABLE TO PROVIDE OTHER DETAILS CONCERNING THE REPORTED EVENT BASED ON THE PATIENT'S OPERATIVE REPORT AND INDICATED THAT THE SURGEON WOULD BE ABLE TO PROVIDE THE SPECIFIC EVENT DETAILS OF THE REPORTED EVENT. NO OTHER INFORMATION WAS PROVIDED. AS OF THE DATE OF THIS REPORT, NO RESPONSE FROM THE SURGEON HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION AS PROVIDED, IT WAS DETERMINED THAT THE DA VINCI SI SURGICAL SYSTEM DID NOT MALFUNCTION IN A WAY THAT WOULD CAUSE NOR CONTRIBUTE TO THE PATIENT'S INJURY; HOWEVER, IT WAS DETERMINED THAT THE PATIENT INJURY OCCURRED AS A RESULT OF THE SURGEON'S MANIPULATION OF THE OBTURATOR INTO THE PATIENT'S BODY WALL. AS OF (B)(4) 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 SI CARDIAC PROCEDURE, WHEN THE SITE MOVED THE TOUCHSCREEN MONITOR, THE TOUCHSCREEN MONITOR WENT DARK. THE SITE PROCEEDED WITH THE CASE USING AN EXTERNAL MONITOR. THE SURGEON CONVERTED THE PROCEDURE TO TRADITIONAL OPEN TECHNIQUES DUE TO AN INJURY TO THE PATIENT'S HEART. REPORTEDLY, DAMAGE TO THE PATIENT'S HEART WAS UNRELATED TO THE VISION ISSUE EXPERIENCED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148528 OBTURATOR ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R DA VINCI SI SURG SYS., INSTRUMENTS AND ACCESSORIE