BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC GRASPER INSTRUMENT

    MDR report key: 3833187 · Received May 27, 2014

    Report

    Report Number
    2955842-2014-03239
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    February 24, 2014
    Report Date
    May 6, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS WAS UNABLE TO CONFIRM THE INITIAL REPORTER'S COMPLAINT. THE GRIPS WERE NOT BENT. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE INSTRUMENT MAIN TUBE HAD SCRATCH MARKS/ ABRASIONS. THE MAIN TUBE INSULATION HAD SCRATCHED AND SOME OF THE INSULATION HAD BEEN REMOVED AT THE DISTAL END. THE SCRATCHES MEASURES APPROXIMATELY .051-.162 IN LENGTH. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE INSTRUMENT FLUSH TUBE WAS KINKED. THE HOUSING WAS REMOVED AND IT WAS NOTED THAT THE FLUSH TUBE EXHIBITED A COUPLE OF KINKS IN THE BACKEND OF THE INSTRUMENT. NO OTHER DAMAGES WERE FOUND ON THE INSTRUMENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE MAIN TUBE HAD SCRATCH MARKS/ ABRASIONS WHICH WERE FOUND DURING FAILURE ANALYSIS INVESTIGATIONS COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI RIGHT VATS PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE TIPS OF THE THORACIC GRASPER INSTRUMENT WAS MISALIGNED DURING THE DA VINCI PROCEDURE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311630 THORACIC GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420343-01 S10130909 025

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR