BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3222809 · Received July 12, 2013

    Report

    Report Number
    2955842-2013-02523
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL, INC. RECEIVED ADDITIONAL INFORMATION FROM THE SURGEON'S SECRETARY REGARDING THE REPORTED EVENT PROVIDING DETAILS CONCERNING THE SURGICAL PROCEDURE AS INDICATED IN THE PATIENT'S OPERATIVE REPORT. INTRAOPERATIVELY THERE WAS AN OCCURRENCE OF TWO ROBOTIC INSTRUMENTS COLLIDING, CAUSING POSSIBLE FRAGMENTATION OF ONE SIDE OF THE ROBOTIC MONOPOLAR SCISSOR TIP INSTRUMENT. THE INSTRUMENT WAS IMMEDIATELY REMOVED FROM THE PATIENT, INSPECTED, AND REMOVED FROM THE FIELD. ON INSPECTION WITH MAGNIFICATION, THE TIP IN QUESTION APPEARED TO BE LESS BLUNTED, SUGGESTING A <0.5MM FRAGMENT AT MOST WAS INVOLVED. THE SURGEON NOTIFIED THE OR'S FRONT DESK OF THE INCIDENT. THE SURGEON INDICATED IN THE PATIENT'S OP REPORT THAT DUE TO THE MINUSCULE SIZE OF THE FRAGMENT/FLAKE OF THE SCISSOR TIP, AN X-RAY WAS NOT APPLICABLE. THE SURGEON INDICATED THAT THERE IS NO CLINICALLY SIGNIFICANT RISK TO THE PATIENT RELATED TO THIS INCIDENT. 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.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE CUSTOMER REPORTED COMPLAINT. A MICROSCOPIC INSPECTION OF THE INSTRUMENT'S BLADE FOUND THAT THE BLADE HAD A CHIPPED SURFACE THAT WAS UNRELATED TO NORMAL WEAR AND TEAR. THE SURFACE WAS NO LONGER STRAIGHT, THE SURFACE WAS UNEVEN AND MATERIAL WAS MISSING. THE INSTRUMENT FAILED A CUT TEST DUE TO THE DAMAGED BLADE. ENGINEERING CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISUSE/MISHANDLING. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS O HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT COLLIDED WITH THE MARYLAND BIPOLAR FORCEPS INSTRUMENT CAUSING A PIECE OF THE BLADE TO BREAK OFF AND FALL INTO THE PATIENT. THE SURGEON SEARCHED FOR THE BROKEN INSTRUMENT PIECE; HOWEVER, IT WAS NOT LOCATED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324259 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-12 S10130531 426

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other DAV SURG SYS., INSTRMNTS, MCS TIP CVR, ACCSS & ES