BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 3960263 · Received July 28, 2014

    Report

    Report Number
    2955842-2014-04550
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 11, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THE INSTRUMENT'S BLADES HAD MECHANICAL INDENTATIONS/BURRS. VISUAL INSPECTION SHOWED INDENTATIONS ON BOTH SIDES OF THE BLADES. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE DA VINCI SYSTEM AND IT FAILED THE CUT TEST. THE INSTRUMENT WAS NOT CUTTING THRU THE THREADING. FAILURE ANALYSIS CONCLUDED THAT THE MECHANICAL INDENTATIONS/BURRS DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. IN ADDITION, THE INSTRUMENT'S GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. FRAYED STRANDS WERE OBSERVED TO BE STICKING OUT AT THE WRIST OF THE INSTRUMENT. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S DISTAL PULLEY HAD SCRATCH MARKS/ABRASIONS. THERE WERE SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED FRAYED CABLE 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 MITRAL VALVE REPAIR SURGICAL PROCEDURE, THE SURGEON NOTICED THAT THE CUTTING SECTION WAS DULL ON THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT AND NOTICED THAT THE CABLE STARTED TO UNRAVEL FROM THE PULLEY JOINT SECTION WHILE UNDER MAGNIFICATION WHEN HE STARTED TO USE IT. ON JULY 14, 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE TO OBTAIN CLARIFICATION CONCERNING THE REPORTED EVENT. IT WAS CONFIRMED THAT THE CABLE WAS FRAYED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437502 LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-04 M10131212 836

    Patients

    Seq Age Sex Outcome Treatment
    1