BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3107943 · Received May 10, 2013

    Report

    Report Number
    2955842-2013-01633
    Event Type
    Other
    Date Received
    May 10, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE FIELD INVESTIGATION, THE INTUITIVE SURGICAL, INC., (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE REPORTED FAILURE MODE EXPERIENCED BY THE SITE. THE FSE EXPERIENCED RESISTANCE MOTION WHILE CONTROLLING AN INSTRUMENT ON PSM 3 AS DESCRIBED BY THE CUSTOMER AFTER AN HOUR OF TESTING. THE FSE ALSO CLUTCHED PSM 3 AND MOVED IT BY HAND, AS A PATIENT SIDE ASSISTANT WOULD DO. THE FSE REPORTED THAT THE OUTER YAW AXIS FELT MORE DIFFICULT TO MOVE THAN EXPECTED. 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 PSM 1 AND PSM 3. PSM 2 WAS REPLACED AS A PRECAUTION. ON (B)(6) 2013, THE INITIAL REPORTER OF THIS COMPLAINT PROVIDED ISI WITH ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE SITE DID NOT EXPERIENCE ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM DURING SET-UP. THE INITIAL REPORTER INDICATED THAT THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE COMPLICATIONS AS A RESULT OF THE REPORTED EVENT AND THAT THE PATIENT WAS IN STABLE CONDITION AFTER SUCCESSFUL COMPLETION OF THE OPEN SURGICAL PROCEDURE. PER THE INFORMATION PROVIDED BY THE INITIAL REPORTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 AND THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. THE PSM 1 PSM 2 AND PSM 3 WERE RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING EVALUATION FOUND THAT THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE WAS DUE TO MECHANICAL INTERFERENCE BETWEEN THE GEARS IN PSM 1 AND PSM 3. THE GEARS WILL BE REPLACED TO REPAIR THE PSMS. AS OF (B)(6) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THIS FAILURE MODE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI GASTRECTOMY PROCEDURE, WHILE THE SURGEON WAS PERFORMING DISSECTION OF THE PATIENT'S HEPATIC ARTERY, THE PATIENT SIDE MANIPULATOR (PSM) ARM 1 BEHAVED IN A SLUGGISH AND RESISTANT MANNER AND INTERMITTENTLY WOULD NOT MOVE WHEN THE SURGEON MANIPULATED THE PSM USING THE RIGHT MASTER TOOL MANIPULATOR (MTMR) ON THE SURGEON SIDE CART. THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207767 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other DA VINCI SI SURG. SYS, INSTRUMENTS & ACCESSORIES.