BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2771259 · Received October 3, 2012

    Report

    Report Number
    2955842-2012-00494
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 7, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K012833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT OF BROKEN CABLE. THE DRIVE CABLES WERE FOUND TO BE INTACT AND UNDAMAGED AT THE WRIST. INSTRUMENT WAS PLACED ON A DAVINCI SYSTEM ROBOT AND DRIVEN. RECOGNITION AND ENGAGEMENT PASSED. INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. GRIPS OPENED AND CLOSED PROPERLY. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS A BENT BIPOLAR PINS. THE TOP PIN WAS BENT DOWN AND THE BOTTOM PIN WAS BENT UP SLIGHTLY SO THAT THE TWO PINS NEARLY MAKE CONTACT. A BIPOLAR CORD CANNOT BE INSTALLED AS A RESULT OF DAMAGE. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS 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 DAVINCI SI SURGICAL PROCEDURE THE CUSTOMER NOTED THAT A 'BROKEN CABLE' ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. 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 M10110831 651

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG SYSTEM, INSTRUMENTS & ACCESSORIE