BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3643132 · Received February 24, 2014

    Report

    Report Number
    2955842-2014-01077
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 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

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S GRIP CABLES TO BE FRAYED. ONE GRIP CLOSE CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. FRAYED STRANDS WERE OBSERVED TO BE STICKING OUT AT THE WRIST OF THE INSTRUMENT. THIS MAY HAVE CAUSED THE CABLE TO BECOME DERAILED FROM THE IDLER PULLEY. THE STRAND THAT STUCK OUT AT THE GRIPS MEASURED ROUGHLY .228. THE SIDE WHERE THE GRIP CABLE WAS DAMAGED, THE MAIN TUBE AND DISTAL HUB EXHIBITED A LONG SCRATCH LEADING UP TO WHERE THE GRIP CABLE WAS LOCATED. IT WAS CONCLUDED THAT THE CONTACT WITH THE OTHER INSTRUMENT/OBJECT MAY HAVE CAUSED GRIP CABLE TO BECOME DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING DAMAGES: THE INSTRUMENT'S BLADES EXHIBITED DAMAGE. ONE BLADE EXHIBITED AN AREA THAT HAD BEEN CHIPPED OFF. THE DAMAGE ON ONE BLADE WAS LOCATED ON THE LOWER PART OF THE BLADE. THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES MEASURED .170 - .185 IN LENGTH AND WAS NOT ALIGNED WITH THE TUBE AXIS. FAILURE ANALYSIS CONCLUDED THAT THE MECHANICAL INDENTATIONS/BURRS DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SACROCOLPOPEXY PROCEDURE, A WIRE BROKE AND WAS EXPOSED ON THE MEGASUTURECUT NEEDLEDRIVER INSTRUMENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112756 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10130528 257

    Patients

    Seq Age Sex Outcome Treatment
    1