BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3980444 · Received August 5, 2014

    Report

    Report Number
    2955842-2014-04710
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    May 26, 2014
    Report Date
    July 8, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT GRIP CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT ANY DAMAGE. THE CABLE SEGMENT STUCK OUT AT THE WRIST APPROXIMATELY .358. ANY POTENTIAL FRAGMENTS WOULD BE RETAINED BY THE TIP COVER. ELECTRICAL CONTINUITY PASSED. ADDITIONAL FINDINGS DURING FAILURE ANALYSIS FOUND THE INSTRUMENT TUBE EXTENSION HAD PAD PRINTING REMOVED. THE TUBE EXTENSION HAD VARIOUS SCRATCHES WITH LIGHT PAD PRINTING REMOVED. FAILURE ANALYSIS CONCLUDED PAD PRINTING DAMAGE IS LIKELY 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE PAD PRINTING DAMAGE WERE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI SURGICAL PROCEDURE, A SMALL CABLE WAS DAMAGED ON THE MONOPOLAR CURVED SCISSORS. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456879 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M10140205 279

    Patients

    Seq Age Sex Outcome Treatment
    1