BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3830848 · Received May 23, 2014

    Report

    Report Number
    2955842-2014-03199
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT OF INSTRUMENT WOULD NOT REGISTER. THERE WAS NO TROUBLE FOUND. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE DA VINCI SYSTEM, RECOGNITION AND ENGAGEMENT PASSED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE SCISSORS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S CUT TEST FAILED. THERE WAS NO BLADE DAMAGE. THE SCISSORS DID NOT CLEANLY CUT THROUGH (B)(4) OF LATEX. THE LATEX GOT SNAGGED AT THE SCISSOR TIPS, BLADE EDGES WERE UNDAMAGED HOWEVER THE EDGES EXHIBITED WEAR AT THE TIPS. THE PAD PRINTING WAS OBSERVED TO BE REMOVED ON THE INSTRUMENT'S TUBE EXTENSION. THERE WAS LIGHT PAD PRINTING REMOVED. FAILURE ANALYSIS CONCLUDED THAT THE PAD PRINTING DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. THE INSTRUMENT'S CLAMPING PULLEY WAS CORRODED AND CONTAMINATED. THE CLAMPING PULLEY AT THE PROXIMAL END INSIDE OF THE HOUSING CONTAINED RUST. FAILURE ANALYSIS CONCLUDED THAT THE CORROSION/CONTAMINATION MAY BE DUE TO IMPROPER CLEANING. 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 MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. THE REPROCESSING INSTRUCTIONS UNDER CLEANING, DISINFECTION, AND STERILIZATION GENERAL INFORMATION SECTION SPECIFICALLY STATES: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WOULD NOT REGISTER. 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
    307675 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M11131207 537

    Patients

    Seq Age Sex Outcome Treatment
    1