BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM NEEDLE DRIVER INSTRUMENT

    MDR report key: 2193051 · Received August 5, 2011

    Report

    Report Number
    2955842-2011-00257
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 6, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    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 FOUND ONE GRIP TO BE BROKEN OFF AND MISSING. THE GRIP FRACTURED AT THE JUNCTION BETWEEN THE GRIP ARM AND GRIP HUB, WHERE THERE IS A 90 DEGREE ANGLE. THE FRACTURED SURFACE EXHIBITS A REDDISH / ORANGE SUBSTANCE, POSSIBLY BIO DEBRIS. THE REMAINING GRIP DOES NOT EXHIBIT DAMAGE. PER THE CASE NOTES THE INSTRUMENT FRAGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. AS OF (B)(4) 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI MYOMECTOMY PROCEDURE, WHILE USING THE 5MM NEEDLE DRIVER INSTRUMENT, THE INSTRUMENT'S ARM BROKE OFF AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THE FRAGMENT WAS IMMEDIATELY REMOVED AND THE INSTRUMENT WAS REPLACED WITH ANOTHER OF THE SAME TYPE. THE PROCEDURE CONTINUED WITH THE REPLACEMENT 5MM NEEDLE DRIVER INSTRUMENT, HOWEVER, THE REPLACEMENT INSTRUMENT'S ARM BROKE IN A SIMILAR FASHION AS THE INITIAL INSTRUMENT. THE SECOND FRAGMENT WAS REMOVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A THIRD REPLACEMENT 5MM NEEDLE DRIVER INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE FOLLOWING MEDWATCH REPORT WAS SENT TO THE FDA AND IS RELATED TO THIS EVENT: 29558842-2011-00XXX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420117-04 S10091116 931

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES