BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 4029076 · Received August 21, 2014

    Report

    Report Number
    2955842-2014-05124
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 28, 2014
    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 REPORTED COMPLAINT, FAILURE ANALYSIS FOUND UPON VISUAL INSPECTION THAT ALL FOUR CLAMPING PULLEYS EXHIBITED CORROSION AT THE BACK END. THE EVIDENCE WAS INCONCLUSIVE, BUT THE CORROSION DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THE FLUSH TUBE WAS DISLODGED FROM THE LUER PLATE. THE LUER PLATE WAS DISCONNECTED FROM THE FLUSH TUBE; HOWEVER THE INSTRUMENT WAS NOT BROKEN NOR TORN. THE EVIDENCE WAS INCONCLUSIVE, BUT DISLODGED DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. THE TWO LEVERS CAME IN TAPED TO THE HOUSING. THERE WAS NO DAMAGE TO THE HOUSING OR THE CHASSIS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .172 - .137 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. 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 CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE TUBE ABRASIONS WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTUITIVE SURGICAL INC., REPRESENTATIVE STERILIZATION EDUCATOR SUSPECTED THE PERMANENT CAUTERY HOOK INSTRUMENT WAS DAMAGED, OPENED THIS INSTRUMENT AND FOUND CORROSION IN CENTRAL PROCESSING. NO FRAGMENTS FELL INTO THE PATIENT, NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505560 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-06 M10121204 442

    Patients

    Seq Age Sex Outcome Treatment
    1