BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 2800417 · Received October 22, 2012

    Report

    Report Number
    2955842-2012-00609
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 25, 2012
    Report Date
    January 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT WITHOUT SUCCESS. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FROM THE SITE. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S GASTRECTOMY PROCEDURE, THE LARGE NEEDLE DRIVER INSTRUMENT BROKE WHILE THE SURGEON WAS SUTURING AND AN INSTRUMENT PIECE FELL INTO THE PATIENT. DURING RETRACTION, A SECOND AND THIRD PIECE CAME OFF. TWO PIECES WERE RETRIEVED - HOWEVER, A 1 MM/2 MM PIN (PART OF THE CABLING SYSTEM) WAS NOT RECOVERED AND REMAINED IN THE PATIENT. THIS WAS VERIFIED BY X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10111205 557

    Patients

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