BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3873048 · Received June 13, 2014

    Report

    Report Number
    2955842-2014-03646
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL FAILURE ANALYSIS INVESTIGATION OBSERVED THAT THE INSTRUMENT EXHIBITED WHITE RESIDUE MATERIAL THAT APPEARED LIKE 'GLUE' SUBSTANCE LOCATED AT THE DISTAL END OF THE MAIN TUBE. THIS WAS NOT INITIALLY REPORTED BY THE SITE. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE WHITE RESIDUE ON THE MAIN TUBE FOUND DURING ADDITIONAL FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S HOUSING HAD LASER MARK ISSUE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING DAMAGES: THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. THE INSTRUMENT'S GRIP TIPS WERE ALSO BENT. ONE GRIP WAS BENT WHICH CAUSED SIDE TO SIDE MISALIGNMENT OF THE GRIP. THERE WAS A 0.014 OFFSET AT THE TIPS. THE BENT GRIP DID NOT EXHIBIT SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, LIKELY CAUSE OF BENDING REMAINS OVERLOADING AT THE TIP. FAILURE ANALYSIS CONCLUDED THAT THE BENT DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. 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 VARIOUS SCRATCH MARKS 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 IN CENTRAL PROCESSING, IT WAS OBSERVED THAT THERE WAS COSMETIC DAMAGE TO THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S HOUSING. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349423 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 470205-05 S10140228 0037

    Patients

    Seq Age Sex Outcome Treatment
    1