BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER

    MDR report key: 2893712 · Received January 2, 2013

    Report

    Report Number
    2955842-2013-00005
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 5, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT SCISSORS DID NOT CUT CLEANLY THROUGH A 0-SILK SUTURE. THE SUTURE GOT SMASHED BETWEEN THE BLADES AND IT REQUIRED MULTIPLE ATTEMPTS TO BE ABLE TO CUT COMPLETELY THROUGH. THE BLADES WERE FOUND TO BE DAMAGED WITH INDENTATIONS. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. ADDITIONAL FINDING NOT REPORTED BY THE SITE WAS MAIN INSULATION TUBE SCRATCHES. THE DISTAL END OF THE MAIN INSULATION TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. 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 DURING A DAVINCI SI HYSTERECTOMY PROCEDURE, THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT 'WOULD NOT CUT SUTURE, NOTHING FELL IN PATIENT OR HARM' NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319 MEGASUTURECUT NEEDLE DRIVER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10121015 895

    Patients

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