BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3970308 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04630
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    April 21, 2014
    Report Date
    July 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 ARTICULATING END ROTATED DURING THE CASE. THERE WAS NO TROUBLE FOUND. THE INSTRUMENT WAS RETURNED WITH ZERO USES LEFT SO IT WAS NOT POSSIBLE TO TEST THE INSTRUMENT FOR ARTICULATION. VISUAL INSPECTION FOUND NO PROBLEMS WITH THE CABLES AT THE DISTAL END OR BACK END. THE INSTRUMENT WAS MANUALLY MOVED AND NO PROBLEMS WERE OBSERVED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S TUBE EXTENSION EXHIBITED REMOVED PAD PRINTING AND VARIOUS SCRATCH MARKS. THE REMOVED PAD PRINTING AREA MEASURED APPROXIMATELY 0.299 X 0.058 - 0.120 X 0.068. FAILURE ANALYSIS CONCLUDED THAT THE PAD PRINTING DAMAGE MAY BE 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 IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE PAD PRINTING DAMAGE IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SALPINGECTOMY SURGICAL PROCEDURE, THE ARTICULATING END ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT ROTATED AND NEEDED TO BE RESET THREE TIMES. 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
    448224 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 M13130808 508

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR