BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3293332 · Received August 16, 2013

    Report

    Report Number
    2955842-2013-03069
    Event Type
    Other
    Date Received
    August 16, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE CAUTERY ISSUE EXPERIENCED BY THE SITE WAS ASSOCIATED WITH THE PERSONALITY MODULE ENERGY DEVICE (PMED). FUNCTIONAL TESTING OF THE SYSTEM FOUND THAT THERE WAS NO LINK ESTABLISHED BETWEEN THE PMED AND ENERGY DEVICES, THUS CAUSING THE ISSUE EXPERIENCED BY THE SITE. THE PMED IS DESIGNED TO INTERFACE AND TO CONTROL FUNCTIONS WITHIN VARIOUS CAUTERY GENERATORS OR ESU'S (ELECTRO-SURGICAL UNIT), WHICH ARE ACTIVATED BY A FOOT PEDAL SWITCH. THE PMED PROVIDES ENHANCED CONTROL, ENABLES MULTIPLE PEDAL INPUTS, MULTIPLE OR EXPANDED GENERATOR CONTROL AND SYSTEM VISIBILITY OF FOOT PEDAL STIMULUS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PMED. THE PMED WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION WAS ABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE. A CAUTERY TEST PERFORMED WITH THE PMED INSTALLED ON A TEST IN-HOUSE SYSTEM FOUND THAT IT WAS NOT RECOGNIZED WHEN THE SYSTEM WAS POWERED ON. ENGINEERING EVALUATION ALSO FOUND THAT THE LIGHT EMITTING DIODES ON THE PMED WERE NOT LIT AND THERE WERE NO COMMUNICATION SIGNALS, THUS INDICATING THAT THE PMED HAD A POWER ISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO OPEN DUE TO A MALFUNCTION OF THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF A DA VINCI SI HYSTERECTOMY PROCEDURE, THE MONOPOLAR AND BIPOLAR CAUTERY ENERGY WERE NOT WORKING. THE SITE POWER CYCLED THE SYSTEM AND RESEATED THE SYSTEM CABLES; HOWEVER, THE ISSUE PERSISTED. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ENGINEERING (TSE) FOR TROUBLESHOOT ASSISTANCE. THE SITE INDICATED TO THE TSE THAT THE LIGHT EMITTING DIODE (LED) INDICATOR AT THE PORT OF THE PERSONALITY MODULE ENERGY DEVICE (PMED) WAS BLUE AND THAT THEY DID NOT HAVE A BACKUP ENERGY CONTROL CABLE. THE SITE STATED THAT THEY SWITCHED TO AN EXTERNAL FOOTSWITCH AND WERE CONTINUING WITH THE CASE. APPROXIMATELY 17 MINUTES LATER, THE ISI CLINICAL SALES REPRESENTATIVE ON SITE FOR THE SURGICAL PROCEDURE CALLED ISI TECHNICAL SUPPORT AND REPORTED THAT THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED PROCEDURE TO OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED. ON (B)(4) 2013, ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER INDICATED THAT THE SURGEON MADE THE DECISION TO COMPLETE THE PROCEDURE USING OPEN SURGICAL TECHNIQUES DUE TO THE CAUTERY ISSUE. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE OPEN PROCEDURE. THE INITIAL REPORTER INDICATED THAT IT WAS NOT REPORTED TO HIM THAT THE PATIENT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397025 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DAV SI SURG SYS. INSTRUMENTS, ACCESSORIES & ESU