BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3844082 · Received June 2, 2014

    Report

    Report Number
    2955842-2014-03379
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE BIPOLAR PINS TO BE BENT. BOTH THE PINS WERE BENT AT THE HOUSING BACK-END. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE WAS DUE TO MISHANDLING. THE DISTAL END OF THE MAIN TUBE HAD SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE 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 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

    ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT FROM THE HOSPITAL. NO INFORMATION CONCERNING THE DEFECT(S) WERE PROVIDED TO ISI. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. CUSTOMER CONFIRMED THAT 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
    321987 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10130903 584

    Patients

    Seq Age Sex Outcome Treatment
    1