BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL GRASPING RETRACTOR INSTRUMENT

    MDR report key: 3843129 · Received June 2, 2014

    Report

    Report Number
    2955842-2014-03357
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 9, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISI HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE INITIAL REPORTER'S COMPLAINT. THE INSTRUMENT PITCH DOWN CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGES OR WEAR MARKS. NO OTHER DAMAGES WERE FOUND ON THE INSTRUMENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION OF BROKEN CABLE FOUND DURING FAILURE ANALYSIS, 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 SIGMOID COLECTOMY PROCEDURE, THE SMALL GRASPING RETRACTOR BROKE. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND VERIFIED THAT THE CABLE WAS BROKEN ON THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322479 SMALL GRASPING RETRACTOR INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420318-04 M10140124 718

    Patients

    Seq Age Sex Outcome Treatment
    1