BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGA NEEDLE DRIVER INSTRUMENT

    MDR report key: 3011688 · Received March 19, 2013

    Report

    Report Number
    2955842-2013-00904
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    September 13, 2012
    Report Date
    February 20, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND WITH A FRAYED PITCH CABLE LOCATED AT DISTAL CLEVIS HUB. THERE WAS NO DAMAGE FOUND AT THE CLEVIS. THE FRAYED SEGMENT WAS APPROXIMATELY 0.04 IN LENGTH. NO OTHER CABLE DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    RECEIVED MEDWATCH REPORT FROM THE CUSTOMER, ACCORDING TO THE MDR REPORT, 'UNDER DIRECT VISUALIZATION DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, ARTICULATING WIRE SNAPPED WHILE THE MEGA NEEDLE DRIVER INSTRUMENT WAS IN USE. NO FRAGMENT OF WIRE WAS NOTED IN SURGICAL FIELD. THE DEVICE WAS REMOVED AND EXAMINED. ONE WIRE NOTED TO BE BROKEN. NO PATIENT HARM OR SURGERY DELAY. X-RAY TOOK POST OPERATION NEGATIVE FOR ANY RETAINED ITEMS.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113219 MEGA NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420194-08 M10120618 310

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES