BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADIERE FORCEPS INSTRUMENT

    MDR report key: 3963925 · Received July 29, 2014

    Report

    Report Number
    2955842-2014-04585
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    May 14, 2014
    Report Date
    July 1, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND ONE GRIP CLOSE CABLE IS FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STICK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN CABLE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PULMONARY LOBECTOMY PROCEDURE, IT WAS NOTED THAT THE WIRES ON THE CADIERE FORCEPS INSTRUMENT WERE NOT INTACT. THERE WAS NO REPORT THAT ANY PIECE(S) FROM THE INSTRUMENT FELL INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT THAT ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441210 CADIERE FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420049-08 M10131126 262

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR