BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3943492 · Received July 18, 2014

    Report

    Report Number
    2955842-2014-04377
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 13, 2014
    Report Date
    July 11, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S GRIP TIPS TO BE BENT. ONE GRIP WAS BENT WHICH CAUSED SIDE TO SIDE MISALIGNMENT OF THE GRIP. THERE WAS A .087 OFFSET AT THE TIPS. THE BENT GRIP DID NOT EXHIBIT SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, HOWEVER LIKELY CAUSE OF BENDING REMAINS OVERLOADING AT THE TIP. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. FAILURE ANALYSIS CONCLUDED THAT THE BENT DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING DAMAGES: THE INSTRUMENT'S PITCH DOWN CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE PITCH CABLE ON THE OTHER SIDE WAS ALSO LOOSE AND STARTING TO UNRAVEL. IN ADDITION, THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD A SCRATCH MARK WITH LIGHT MATERIAL REMOVAL. THE SCRATCH MEASURED APPROXIMATELY 0.231 IN LENGTH AND WAS NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE FRAYED CABLE AND SCRATCH MARK ON THE MAIN TUBE WITH LIGHT MATERIAL REMOVAL FOUND DURING FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE JAWS ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WERE BENT AND NOT ALIGNED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422679 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 N10140305 740

    Patients

    Seq Age Sex Outcome Treatment
    1