BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3140317 · Received May 31, 2013

    Report

    Report Number
    2955842-2013-01941
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    February 24, 2013
    Report Date
    May 6, 2013
    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. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE CONNECTOR PIN WAS MISSING AND NO BANANA PLUG WAS FOUND, BUT THERE WERE LOOSE SCREWS FOUND INSIDE HOUSING. THERE WAS NO ADDITIONAL DAMAGE FOUND ON NEITHER THE PROXIMAL NOR THE DISTAL END. THE COMPLAINT STATED THAT THE INSTRUMENT WAS NEVER USED; HOWEVER, THE INSTRUMENT WAS RETURNED SHOWING 9 USES REMAINING. THE SYSTEM ERROR LOGS WERE REVIEWED AND THEY SHOWED THAT THE MCS INSTRUMENT WAS INSTALLED ON THE DA VINCI SYSTEM ON (B)(4) 2013. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS MAIN TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. 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 ADDITIONAL FINDING OF MAIN TUBE SCRATCHES 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 PROSTATECTOMY PROCEDURE, WHEN THE CUSTOMER REMOVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT OUT OF THE BOX, THEY NOTED THAT THE CONNECTION PIN WAS MISSING FROM THE INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. SINCERELY,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242073 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10121219 574

    Patients

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