BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3081522 · Received April 29, 2013

    Report

    Report Number
    2955842-2013-01424
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 29, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING DID NOT CONFIRM THE ALLEGED COMPLAINT. THE INSTRUMENT WAS CHECKED FOR RECOGNITION AND MOVEMENT ON AN IN-HOUSE SYSTEM. RECOGNITION AND ENGAGEMENT PASSED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT'S BLADES OPENED AND CLOSED WITH NO PROBLEM AND IT PASSED THE CUT TEST. ADDITIONAL OBSERVATION NOT INITIALLY REPORTED BY THE SITE WAS MAIN TUBE DAMAGE. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE EXHIBITED A DEEP SCRATCH MARK WITH LIGHT MATERIAL REMOVAL AND HAD A ROUGH SURFACE FINISH. ENGINEERING CONCLUDED THAT THE DAMAGE MAY BE DUE TO MISHANDLING. ELECTRICAL CONTINUITY TESTING WAS PERFORMED ON THE INSTRUMENT AND PASSED. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) 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 REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE ROBOT WOULD NOT ADVANCE THE MONOPOLAR CURVED SCISSORS INSTRUMENT PROPERLY. NO MISSING OR FALLEN PIECES WERE REPORTED. THE INSTRUMENT REPORTEDLY WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184483 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M11130112 770

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES, ESU