BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURE CUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3081381 · Received April 26, 2013

    Report

    Report Number
    2955842-2013-01422
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING DID NOT CONFIRM THE ALLEGED COMPLAINT. THE GRIP CABLE WAS FOUND BROKEN NOT FRAYED AT THE DISTAL IDLERS AND THE CABLE SEGMENT WAS STICKING OUT AT WRIST. THE IDLER PULLEY SPUN FREELY BUT WAS FOUND WITH DAMAGE. THE DISTAL IDLER PULLEY HAD AN INDENTATION AT THE EDGE. ENGINEERING CONCLUDED THAT THE DAMAGE MAY BE DUE TO MISHANDLING. OTHER CABLES AT INSTRUMENT'S WRIST WERE NOT DAMAGED. ADDITIONAL OBSERVATION NOT INITIALLY REPORTED BY THE SITE WAS CORROSION ON THE BACK IDLER PULLEYS. YELLOWISH RESIDUE WAS FOUND IN BETWEEN EACH OF THE PULLEYS AT THE EDGES. ENGINEERING CONCLUDED THAT THE DAMAGE MAY BE DUE TO IMPROPER CLEANING. 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

    DURING CENTRAL PROCESSING, THE USER FACILITY IDENTIFIED FRAYED WIRES ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT . NO MISSING OR FALLEN PIECES WERE REPORTED. THE INSTRUMENT REPORTEDLY 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
    180832 MEGASUTURE CUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10121205 154

    Patients

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