BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS

    MDR report key: 2810196 · Received October 31, 2012

    Report

    Report Number
    2955842-2012-00746
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 2, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STICK OUT AT THE WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. ADDITIONAL FINDING NOT REPORTED BY THE SITE WAS DERAILED GRIP CABLE. SAME FRAYED GRIP CABLE WAS ALSO FOUND TO BE DERAILED AT THE DISTAL IDLER PULLEY. THE GRIPS CABLES WERE ABLE TO OPEN AND CLOSE, BUT THEIR MOVEMENT COULD NOT BE PRECISE. THE CABLE DERAILMENT WAS LIKELY DUE TO THE CABLE LOSING CONTACT WITH PULLEY DURING WRIST ARTICULATION. ADDITIONAL FINDING NOT REPORTED BY THE SITE WAS BROKEN INPUT DISC FROM THE BOTTOM OF THE BACK HOUSING. A PIECE OF INPUT DISC WAS FOUND TO BE BROKEN. THE BROKEN PIECE WAS MEASURED ROUGHLY ABOUT 0.743 X 0.204 AND THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT. DURING FAILURE ANALYSIS THE ENGINEERS ALSO OBSERVED SOME SCRATCHES ON MAIN INSULATION TUBE. THE DISTAL END OF THE MAIN INSULATION TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. 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. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. 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 A DAVINCI SI HYSTERECTOMY PROCEDURE, THE CUSTOMER NOTED A 'FRAYED WIRE AT THE TIP' ON THE PK DISSECTING FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK DISSECTING FORCEPS ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120425 184

    Patients

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