BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2832865 · Received November 14, 2012

    Report

    Report Number
    2955842-2012-00932
    Event Type
    Other
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE PROBLEM EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH STERILE ADAPTER. THE INSTRUMENT STERILE ADAPTER IS PART OF THE INSTRUMENT ARM DRAPE AND PROVIDES THE POINT OF CONNECTION BETWEEN THE INSTRUMENT AND THE INSTRUMENT ARM. THE PSMS ARE INSTRUMENT ARMS LOCATED ON THE PATIENT CART THAT PROVIDE THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS TESTED AND PERFORMED TO ORIGINAL EQUIPMENT MANUFACTURER SPECIFICATIONS. AS OF (B)(4) 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 PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED PROBLEMS GRIPPING WITH INSTRUMENTS LOCATED ON PSM1 AND PSM2 OF THE SYSTEM. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE SITE ATTEMPTED TO ROTATE STERILE ADAPTER DISCS; HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PROCEDURE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY 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 SYSTEM INSTRUMENTS AND ACCESSORIES