BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3983484 · Received August 6, 2014

    Report

    Report Number
    2955842-2014-04747
    Event Type
    Other
    Date Received
    August 6, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CABLE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. INTUITIVE SURGICAL INC. (ISI) HAS ATTEMPTED TO CONTACT THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI PROCEDURE POST ANESTHESIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI PROSTATECTOMY PROCEDURE, THE VISION THROUGH ONE OF THE EYES WOULD GO OUT WHEN MOVING THE CAMERA CABLE. THE INITIAL REPORTER MENTIONED THAT IF NOBODY TOUCHED THE CAMERA CABLE, THE IMAGES WERE OK. DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO ABORT THE SURGICAL PROCEDURE POST ANESTHESIA. A CAMERA CABLE WAS SENT TO THE SITE TO RESOLVE THE REPORTED ISSUE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459319 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other