BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3573317 · Received January 14, 2014

    Report

    Report Number
    2955842-2014-00232
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    November 26, 2013
    Report Date
    December 17, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THAT MANIPULATION OF THE INSTRUMENT INPUT WHEELS OPENED AND CLOSED THE JAWS OF THE INSTRUMENT AS INTENDED. AN OBSERVATION NOT REPORTED BY THE SITE IS THAT THE DISTAL END OF MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SCRATCHES ARE APPROXIMATELY .150 - .232 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. IT WAS CONCLUDED THAT THE DAMAGE WAS LIKELY DUE MISHANDLING/MISUSE. 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 MDR REPORTABLE EVENT; HOWEVER, THE TUBE ABRASIONS, IF TO RECUR, COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REPROCESSING OF A DA VINCI MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT, THE JAWS WOULDN'T OPEN. NO MISSING OR FALLEN PIECES WERE REPORTED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37308 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M20120413 270

    Patients

    Seq Age Sex Outcome Treatment
    1