BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 3813017 · Received May 15, 2014

    Report

    Report Number
    2955842-2014-02997
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    January 14, 2014
    Report Date
    May 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS NOT ABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT OF JAWS ARE MISALIGNED. THE GRIPS WERE NOT BENT. FAILURE ANALYSIS INVESTIGATION FOUND THE FOLLOWING DAMAGES: THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE MAIN TUBE APPEARED TO HAVE A STRIPPED EPOXY COATING LAYER. THIS RESULTS IN THE FIBER GLASS LAYER UNDERNEATH THE EPOXY LAYER TO BE EXPOSED. THIS DAMAGE OCCURS ALONG THE ENTIRE LENGTH OF THE MAIN TUBE. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE MAY HAVE BEEN DUE TO IMPROPER CLEANING. THE INSTRUMENT'S GRIP CABLE WAS BROKEN AT THE HYPOTUBE. THE CABLE FRAGMENTS WAS OBSERVED TO BE STICKING OUT AT THE TIP OF THE INSTRUMENT. THE LENGTH OF THE BROKEN FRAGMENT INDICATES THAT THE INSTRUMENT WAS BROKEN IN THE HYPOTUBE. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE MAY HAVE BEEN DUE TO IMPROPER CLEANING. THE INSTRUMENT'S PITCH CABLE AND CRIMP WERE MISSING FROM THE INSTRUMENT TIP. THE PITCH CABLE WAS VERY LOOSE AT THE HOUSING. THE INSTRUMENT WAS NEVER USED. NO OTHER DAMAGE WAS FOUND. THE REPROCESSING INSTRUCTIONS UNDER CLEANING, DISINFECTION, AND STERILIZATION GENERAL INFORMATION SECTION SPECIFICALLY STATES: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE. 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 BROKEN CABLE 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 THE JAWS ON THE TENACULUM FORCEPS INSTRUMENT WERE MISALIGNED. 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
    290847 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420207-06 M10110831 485

    Patients

    Seq Age Sex Outcome Treatment
    1