BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS

    MDR report key: 2890257 · Received December 29, 2012

    Report

    Report Number
    2955842-2012-01475
    Event Type
    Malfunction
    Date Received
    December 29, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING COULD NOT CONFIRM CUSTOMER REPORTED COMPLAINT OF AN EXPOSED WIRE. HOWEVER, FINDINGS REVEALED CHAR MARKS ON THE YAW PULLEY AND SCRATCHES ON THE MAIN TUBE. BOTH YAW PULLEYS EXHIBIT CHARRING AND LOCALIZED MELTING AT THE GRIP BASE. DAMAGE WAS CAUSED MOST LIKELY FROM ANOTHER INSTRUMENT. DISTAL END OF MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL, SUGGESTING IT MAY HAVE BEEN CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. ELECTRICAL CONTINUITY PASSED. THE INSTRUMENT HAS 5 USES LEFT. INTERNAL LABORATORY TESTING HAS DETERMINED THAT THE ARC TRACK FAILURE MODE IS MOST LIKELY TO OCCUR WHEN A BIPOLAR INSTRUMENT IS ENERGIZED WITH NO TISSUE BETWEEN THE GRIPS. INTERNAL ARCING IN BIPOLAR INSTRUMENTS RESULTS IN A POTENTIAL LOSS OF PRODUCT FUNCTION, BUT NO TRANSFER OF ENERGY TO THE PATIENT. INTUITIVE HAS CONCLUDED THAT THE LIKELIHOOD OF INJURY DUE TO THIS FAILURE IS REMOTE. USERS ARE INSTRUCTED TO RETAIN BACK-UP INSTRUMENTS IN CASE THAT AN INSTRUMENT FAILS TO PERFORM, AND ARE ALSO INSTRUCTED IN PROPER TECHNIQUE TO MINIMIZE THE LIKELIHOOD OF INTERNAL ARCING. PER THE CUSTOMER, AT THE TIME OF THE REPORTED EVENT, NOTHING FELL INTO A PATIENT DURING A SURGICAL PROCEDURE. BASED ON THIS, NO ADDITIONAL FOLLOW UP IS REQUIRED. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVE. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, AN EXPOSED WIRE WAS NOTED 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 ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10121003 135

    Patients

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