BEUDAMED
    FDA Adverse Event Other Summary report: N

    12 MM ENDOSCOPE, 30 DEGREE

    MDR report key: 3484681 · Received November 22, 2013

    Report

    Report Number
    2955842-2013-05390
    Event Type
    Other
    Date Received
    November 22, 2013
    Date of Event
    October 24, 2013
    Report Date
    October 24, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 12 MM ENDOSCOPE WAS RETURNED AND EVALUATED. THE REPORTED CUSTOMER FAILURE MODE WAS CONFIRMED WITH THE EVALUATION OF THE ENDOSCOPE. THE ENDOSCOPE WAS RECEIVED WITH MECHANICAL DAMAGE TO THE DISTAL WINDOW ASSEMBLY HERMETIC SEAL RESULTING IN FLUID INVASION AND SUBSEQUENT MINOR DAMAGE TO OPTICAL COMPONENTS. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROSTATECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING AN IMAGE ISSUE WITH THE ENDOSCOPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED AN IMAGE ISSUE WITH THE 12 MM ENDOSCOPE, 30º WHERE A HALF MOON SHAPE APPEARED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROSTATECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609235 12 MM ENDOSCOPE, 30 DEGREE ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 370893-03

    Patients

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