BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3870770 · Received June 12, 2014

    Report

    Report Number
    2955842-2014-03624
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S GRIP CABLE WAS FRAYED. THE DRIVE CABLE WAS FRAYED. ONE GRIP CLOSE CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. FRAYED STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S TUBE EXTENSION PAD PRINTING WAS REMOVED. THERE WAS A SMALL AREA WITH PAD PRINTING REMOVED 0.049 X 0.036. FAILURE ANALYSIS CONCLUDED THAT THE PAD PRINTING REMOVAL WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, IT WAS NOTED THAT BROKEN PULLEY WIRES WERE NOTED ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346908 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10140217 894

    Patients

    Seq Age Sex Outcome Treatment
    1