BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2072780 · Received April 29, 2011

    Report

    Report Number
    2955842-2011-00132
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K012833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED A PIECE OF THE YAW PULLEY COVER DETACHED FROM THE INSTRUMENT. THE BROKEN PIECE IS APPROXIMATELY .240 X .200 IN SIZE. THE BROKEN PIECE HAD FRACTURED AROUND THE DISTAL PIN AND THE YAW PULLEY COVER HAS TWO BROKEN SECTIONS STILL WITHIN THE CLEVIS. THE BELLEVILLE WASHER ON THE BROKEN SIDE HAS NO LOAD ON ONE SIDE AND AS A RESULT OF THE BREAKAGE, IS TILTED WITHIN THE CLEVIS. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE A PIECE OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT FELL INTO THE PATIENT. THE FRAGMENTED PIECE WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT OF THE SAME TYPE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10101118 952

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM, ACCS., & ESU