BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2533805 · Received April 12, 2012

    Report

    Report Number
    2955842-2012-00162
    Event Type
    Other
    Date Received
    April 12, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 13, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE CUSTOMER. HOWEVER, THE FSE FOUND THAT THE PATIENT SIDE MANIPULATOR (PSM) ARMS CABLE TENSIONS WERE LOW. THE FSE CONCLUDED THAT THE ISSUE EXPERIENCED BY THE CUSTOMER WAS LIKELY DUE TO A COMBINATION OF THE PSM ARM LOW CABLE TENSION AND A POORLY SEATED OR BAD STERILE ADAPTER. THE STERILE ADAPTER IS PART OF THE DISPOSABLE DRAPE ISOLATING THE NON-STERILE PSM FROM THE STERILE FIELD. IT ATTACHES TO THE PSM ON ONE SIDE AND HOLDS THE STERILE INSTRUMENT ON THE OTHER SIDE. FOUR DISKS ON THE STERILE ADAPTER ALLOW MOTORS ON THE PSM TO CONTROL MOTION OF THE INSTRUMENT WRIST. IF THE CONNECTION BETWEEN THE ADAPTER AND EITHER THE PSM OR THE INSTRUMENT IS INCORRECT, IT CAN LEAD TO NON-INTUITIVE MOTION. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART AND PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE FSE READJUSTED THE PSM ARM CABLE TENSIONS TO REPAIR THE SYSTEM. THE FSE PERFORMED SYSTEM DIAGNOSTICS AND VERIFICATION AND FOUND THAT THE SYSTEM IS FUNCTIONING WITHIN SPECIFICATION. ON (B)(6) 2012 ISI CONTACTED RN, (B)(6) (SURNAME UNKNOWN) AT (B)(6) HOSPITAL AND HE INDICATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE AND THAT THE SITE WAS ABLE TO RESOLVE THE ISSUE THE SECOND TIME WITH THE ASSISTANCE OF ISI TECHNICAL SUPPORT ENGINEERING, HOWEVER, AFTER SOME TIME THE ISSUE REOCCURRED AND THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. THERE WAS NO HARM TO THE PATIENT, THE PATIENT TOLERATED THE OPEN PROCEDURE WELL AND TO THE BEST OF HIS KNOWLEDGE, THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-OPERATIVE COMPLICATIONS. AS OF APRIL 12, 2012, 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 HYSTERECTOMY PROCEDURE, WHEN THE PK DISSECTING INSTRUMENT WAS INSTALLED ON A PATIENT SIDE MANIPULATOR (PSM) ARM, THE INSTRUMENT GRIPS WOULD NOT CLOSE PROPERLY AND THE SURGEON EXPERIENCED NON-INTUITIVE MOVEMENT. THE SITE INSTALLED A REPLACEMENT PK DISSECTING FORCEPS INSTRUMENT; HOWEVER, THE ISSUE PERSISTED. THE SITE CONTACTED ISI TECHNICAL SUPPORT ENGINEERING (TSE) FOR TROUBLE SHOOTING ASSISTANCE AND WAS INSTRUCTED BY THE TSE TO REMOVE THE INSTRUMENT AND RESEAT THE STERILE ADAPTER. THE SITE INDICATED THAT THE ISSUE HAD IMPROVED AND WAS ABLE TO PROCEED WITH THE PROCEDURE. APPROXIMATELY 20 MINUTES LATER, THE SITE CONTACTED ISI TECHNICAL SUPPORT TO REPORT THAT THE ISSUE HAD RETURNED, THE ISSUE WAS ALSO NOTED ON A SECOND PSM. THE TSE INSTRUCTED THE SITE TO REMOVE ALL OF THE INSTRUMENTS INSTALLED AND PERFORM A POWER CYCLE OF THE SYSTEM. AFTER POWERING ON THE SYSTEM, THE SITE CONFIRMED WITH THE TECHNICAL SUPPORT ENGINEER THAT THE SYSTEM WAS FUNCTIONING WITH NO ISSUES NOTED; HOWEVER, THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

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