BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3000097 · Received March 8, 2013

    Report

    Report Number
    2955842-2013-00780
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS RETURNED WITH A FRAYED PITCH LOOSE CABLE AT DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS AND NO OTHER CABLE DAMAGE WAS FOUND. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING EVALUATION ALSO FOUND THAT ONE GRIP WAS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A .038 OFFSET AT THE TIPS, INDICATING OVERLOADING AT THE TIP. ENGINEERING CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO 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.

    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 MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET UP OF A DA VINCI SI SURGICAL PROCEDURE THE WIRE AT THE DISTAL END OF THE PK DISSECTING FORCEPS INSTRUMENTS WAS NOTED TO BE FRAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98739 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT, NAY NAY INTUITIVE SURGICAL,INC. 420227-03 M10120621 483

    Patients

    Seq Age Sex Outcome Treatment
    1 ESU| INSTRUMENTS| DA VINCI SI SURG. SYS.| ACCSS