BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC GRASPER INSTRUMENT

    MDR report key: 2914523 · Received January 14, 2013

    Report

    Report Number
    2955842-2013-00176
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(4) 2012, ISI CONTACTED THE INITIAL REPORTER OF THIS REPORT. THE INITIAL REPORTER INDICATED THAT THERE WAS NO REPORT BY THE SURGICAL STAFF THAT ANY PIECES FROM THE INSTRUMENT FELL INTO THE PATIENT. THE INITIAL REPORTER INDICATED THAT TO THE BEST OF HER KNOWLEDGE IT IS UNKNOWN IF THE PATIENT HAS RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST SURGICAL COMPLICATIONS RELATED TO RETAINING ANY FOREIGN BODY. THE INITIAL REPORTER INDICATED THAT IT IS UNKNOWN IF THE CANNULA WAS INSPECTED PRIOR TO USE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI LOBECTOMY PROCEDURE, IT WAS NOTED THAT THE COATING ON MAIN TUBE OF THE THORACIC GRASPER WAS PEELING. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20202 THORACIC GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420343-01 S10120809 876

    Patients

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