BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3092393 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01530
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    February 27, 2013
    Report Date
    April 8, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH UP CABLE WAS FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. NO OTHER DAMAGE FOUND. 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 DA VINCI SI HYSTERECTOMY PROCEDURE, THE CUSTOMER REPORTED THAT WHILE THE SURGEON WAS SUTURING, THE WIRE OF THE MEGA NEEDLE DRIVER INSTRUMENT SNAPPED OFF. THE INSTRUMENT WAS REPLACED AND THE SURGICAL PROCEDURE WAS COMPLETED AS PLANNED. THE PROCEDURE WENT WELL AND WITH NO INCIDENT TO THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195348 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10120621 262

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES