BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3943600 · Received July 18, 2014

    Report

    Report Number
    2955842-2014-04380
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 8, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S GRIP CABLE TO BE BROKEN AT THE DISTAL IDLER. THE IDLER PULLEY SPUN FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT WAS OBSERVED TO BE STICKING OUT AT THE WRIST OF THE INSTRUMENT. THE OTHER CABLES AT THE WRIST OF THE INSTRUMENT WERE UNDAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING DAMAGES: THE INSTRUMENT'S DISTAL PULLEY HAD MECHANICAL INDENTATIONS/BURRS. THERE WERE INDENTATIONS AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. FAILURE ANALYSIS INVESTIGATION CONCLUDED THAT THE MECHANICAL INDENTATIONS/BURRS DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. IN ADDITION, THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD A SCRATCH MARK WHICH EXHIBITED LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCH WAS SHORT IN LENGTH AND WAS NOT AXIALLY ALIGNED WITH THE TUBE. 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 BROKEN CABLE AND SCRATCH MARK ON THE MAIN TUBE WITH LIGHT MATERIAL REMOVAL FOUND DURING FAILURE ANALYSIS 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 INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CABLES BROKE ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WHEN THE SURGEON WAS SUTURING. 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
    422769 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-03 M10140411 726

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR