BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3173134 · Received June 17, 2013

    Report

    Report Number
    2955842-2013-02188
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 28, 2013
    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. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE ONE GRIP WAS BENT, CAUSING SIDE-TO-SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A .17 OFFSET AT THE TIPS. THE BENT GRIP HAD SEPARATION OF THE YAW PULLEY AND THE PULLEY COVER AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING ALSO OBSERVED THAT THE INSTRUMENT PITCH CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. THE FRAYED SEGMENT WAS APPROXIMATELY 0.03 IN LENGTH. NO OTHER CABLE DAMAGE WAS FOUND. 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. O 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. 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.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE ONE GRIP WAS BENT, CAUSING SIDE-TO-SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A .17 OFFSET AT THE TIPS. THE BENT GRIP HAD SEPARATION OF THE YAW PULLEY AND THE PULLEY COVER AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING ALSO FOUND THE PITCH CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. THE FRAYED SEGMENT WAS APPROXIMATELY 0.03 IN LENGTH. NO OTHER CABLE DAMAGE WAS FOUND. 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 A DA VINCI SI TOTAL BENIGN HYSTERECTOMY PROCEDURE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT SHAFT WAS NOTED TO BE BENT AND WOULD NOT GRASP OR CLOSE. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274078 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10120629 132

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES