BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3872119 · Received June 13, 2014

    Report

    Report Number
    2955842-2014-03636
    Event Type
    Other
    Date Received
    June 13, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE ISI FIELD SERVICE ENGINEER (FSE) CONCLUDED THAT THE ISSUE EXPERIENCED BY THE SITE WAS ASSOCIATED WITH A PIN IN THE RECEPTACLE OF THE ICB. THE PIN WAS FOUND TO BE BENT. THE FSE STRAIGHTENED THE PIN TO REPAIR THE ICB. FUNCTIONAL TESTING OF THE ICB USING A TEST ENDOWRIST ONE VESSEL SEALER SIMULATOR INSTRUMENT FOUND THAT THE STRAIGHTENED PIN CORRECTED THE ISSUE. THE ICB CONTROLS THE BLADE CUT FUNCTION OF THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI SIGMOID COLECTOMY PROCEDURE, THE SITE WAS UNABLE TO INSTALL AN ENDOWRIST ONE VESSEL SEALER INSTRUMENT INTO THE INSTRUMENT CONTROL BOX, CAUSING THE SURGEON TO CONVERT THE PLANNED PROCEDURE TO OPEN SURGICAL TECHNIQUES. AS OF (B)(4) 2014, 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 SIGMOID COLECTOMY PROCEDURE, THE SITE WAS UNABLE TO INSTALL THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT INTO THE RECEPTACLE OF THE INSTRUMENT CONTROL BOX (ICB). THE SITE ATTEMPTED TO INSTALL A REPLACEMENT INSTRUMENT INTO THE ICB; HOWEVER, THE ISSUE PERSISTED. PRIOR TO CONTACTING INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ASSISTANCE THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED. ON (B)(4) 2014, ISI CONTACTED THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE PATIENT. ACCORDING TO THE OR NURSE THE PATIENT TOLERATED THE OPEN PROCEDURE AND THERE WAS NO HARM TO THE PATIENT AS RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349028 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other