BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3052820 · Received April 11, 2013

    Report

    Report Number
    2955842-2013-01193
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    May 1, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE INITIAL MDR SUBMITTED ON (B)(4) 2013 HAS BEEN RECLASSIFIED AS A NON-REPORTABLE EVENT SINCE THE RECURRENCE OF THE FAILURE MODES ARE NOT EXPECTED TO BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT. NO ADVERSE EVENTS HAVE OCCURRED RELATED TO THESE FAILURE MODES.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE BROKEN BLADE ON THE INSTRUMENT. THE INSTRUMENT BLADE WAS FOUND WITH AN INDENTATION NEAR THE BLADE'S TIP. THE SCISSORS DID NOT FULLY CLOSE DUE TO THE BLADE DAMAGE. AS A RESULT, THE BLADES DID NOT CUT THROUGH THEIR ENTIRE LENGTH AND THE CUT TEST FAILED. ONE BLADE'S EDGE HAD AN INDENTATION BETWEEN THE MIDPOINT AND TIP THAT ACTED AS A MECHANICAL STOP FOR THE OTHER BLADE WHEN CLOSING. ENGINEERING CONCLUDED THAT DAMAGES MAY BE DUE TO MISHANDLING. ELECTRICAL CONTINUITY TESTING WAS PERFORMED ON THE INSTRUMENT AND PASSED. AN ADDITIONAL FINDING NOT REPORTED BY THE SITE WAS CORROSION FOUND ON THE DARK TUBE REINFORCEMENT RING. THERE WERE SEVERAL SPOTS ON THE RING, WHICH REVEALED THE METAL SURFACE LOCATED RIGHT ABOVE THE TUBE EXTENSION. NO OTHER DAMAGE WAS FOUND WITH THE INSTRUMENT. 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

    PRIOR TO STARTING A DA VINCI SI PROCEDURE, THE USER FACILITY REPORTEDLY IDENTIFIED A BROKEN BLADE FROM THE MONOPOLAR CAUTERY INSTRUMENT. THE INSTRUMENT 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
    155705 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M13130111 552

    Patients

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