BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2139779 · Received June 24, 2011

    Report

    Report Number
    2955842-2011-00201
    Event Type
    Other
    Date Received
    June 24, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER DETERMINED THAT THE CUSTOMER REPORTED ISSUE WAS ASSOCIATED WITH THE PATIENT SIDE MANIPULATOR (PSM). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE PSM. THE PSM WAS RETURNED AND EVALUATED. ENGINEERING WAS NOT ABLE TO REPLICATE THE REPORTED FAILURE MODE; HOWEVER, SUSPECT COMPONENTS WERE REPLACED TO REPAIR THE PSM. AS OF (B)(6) 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USING THE SYSTEM TO PERFORM ANY SURGICAL TASKS FOR A DA VINCI S PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF WAS UNABLE TO INSERT AN INSTRUMENT ON THE PATIENT SIDE MANIPULATOR (PSM). THE SITE ATTEMPTED TO TROUBLESHOOT BY REBOOTING THE SYSTEM; HOWEVER, THE ISSUE PERSISTED. THE PATIENT HAD BEEN UNDER ANESTHESIA AND PORT INCISIONS HAD BEEN CREATED WHEN THE SURGEON MADE THE DECISION TO ABORT 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. IS2000 5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SYSTEM INSTRUMENT AND ACCESSORIES