BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3183187 · Received June 21, 2013

    Report

    Report Number
    2955842-2013-02265
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 23, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LARGE NEEDLE DRIVER INSTRUMENT WAS RETURNED AND EVALUATED. BASED ON A VISUAL INSPECTION OF THE INSTRUMENT, THE DISTAL END OF THE MAIN TUBE EXHIBITED A 1.04 LONG SECTION WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE, LEAVING A ROUGH SURFACE FINISH. ENGINEERING EVALUATION CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING AND CONSISTENT WITH THE REPORTED ACCIDENTAL MORCELLATION. NO OTHER INSTRUMENT DAMAGE WAS FOUND. ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE INITIAL REPORTER. THE INITIAL REPORTER INDICATED THAT ALL FRAGMENTS WERE RETRIEVED AND AN X-RAY WAS PERFORMED AS AN ATTEMPT TO LOOK FOR POSSIBLE RETAINED FRAGMENTS. THE X-RAY RESULTS WERE NEGATIVE. THE INITIAL REPORTER INDICATED THAT THERE WAS NO ADVERSE OUTCOME TO THE PATIENT DUE TO THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: TWO FRAGMENTS FROM THE SHAFT OF THE LARGE NEEDLE DRIVER INSTRUMENT FELL INTO THE PATIENT AND WERE RETRIEVED. IN ADDITION, AN X-RAY WAS PERFORMED ON THE PATIENT IN AN ATTEMPT TO LOOK FOR POSSIBLE RETAINED FRAGMENTS. HOWEVER, THERE IS NO EVIDENCE THAT A MALFUNCTION OF THE INSTRUMENT OCCURRED DURING THE SURGICAL PROCEDURE. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE SHAFT OF THE LARGE NEEDLE DRIVER INSTRUMENT WAS ACCIDENTALLY MORCELLATED WHILE THE SURGICAL STAFF WAS MORCELLATING A FIBROID IN THE PATIENT'S PELVIC CAVITY. TWO FRAGMENTS FROM THE LARGE NEEDLE DRIVER INSTRUMENT FELL INTO THE PATIENT BUT WERE RETRIEVED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282921 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10120824 157

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES