BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ STRAIGHT HANDPIECE

    MDR report key: 3901656 · Received May 6, 2014

    Report

    Report Number
    3006697299-2014-00034
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED, SRAGH, TULLAMORE, CO.
    Product Code
    LFL
    PMA / PMN Number
    K981262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 05DEC2014. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: IT WAS OBSERVED DURING INVESTIGATION THAT THE NOSE CONE O RING WAS WHITE AND FOR 23KHZ HANDPIECE THE O RING SHOULD BE GREEN. AFTER THE HANDPIECE WAS TESTED FOR 25 MINUTES (10MINUTES ON, 5MINUTES OFF, 10 MINUTES ON),TEMPERATURES AT THE NOSE CONE WERE WITHIN THE IT0029 RELEASE CRITERIA. FOLLOWING THE TESTS THERE WAS NO FAULT FOUND. THE MANUFACTURING PAPERWORK WAS COMPLETED CORRECTLY FOLLOWING COMPANY WORK INSTRUCTIONS. NO CONCESSIONS ARE LISTED ON THE PAPERWORK. OF PARTICULAR NOTE, THE TEST RECORD SHOWS THAT TEST "MAXIMUM HAND PIECE TEMPERATURE" AND "COOLANT FLOW" WERE PERFORMED SATISFACTORY PRIOR TO THE UNIT BEING RELEASED. A MINIMUM OF 12 MONTHS REVIEW WAS COMPLETED USING THE FOLLOWING KEY WORDS ¿OVERHEATING¿ AND ROOT CAUSE ¿COULD NOT DUPLICATE¿ IN THE SEARCH CRITERIA. THIS REVIEW ENCOMPASSED FROM DATES 18-APRIL-2014 TO 16-DEC-2015 IN WHICH 1 COMPLAINT CONTAINED THE SEARCH CRITERIA. THE ANALYSIS OF THE COMPLAINT INVESTIGATIONS AND ROOT CAUSE REPORTS HAS CONCLUDED THAT THIS COMPLAINT IS THE FIRST IDENTIFIED COMPLAINT FOR THE CUSA EXCEL C2600 HANDPIECE FOR THE REPORTED FAILURE ROOT CAUSE IDENTIFIED AS ¿COULD NOT DUPLICATE¿ RESULTING IN HANDPIECE ISSUE. THE FAILURE ANALYSIS INVESTIGATION HAS CONCLUDED THE CAUSE OF THE HANDPIECE GOT HOT WHEN STARTED TO BE USED, SHOT WATER OUT OF TIP WAS NOT CONFIRMED, THEREFORE NO FAULT FOUND, CUSTOMER COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE WAS INSTRUCTING THE USER THROUGH THE ASSEMBLY OF THE HANDPIECE. EVERYTHING WENT AS DIRECTED. WHEN THE DOCTOR STARTED USING THE HANDPIECE, IT WOULD GET VERY HOT. THE DOCTOR THEN PUT THE TIP IN A CUP OF WATER AND STEPPED ON THE FOOT PEDAL. THE HANDPIECE "SHOT WATER OUT OF THE CUP" AND ALMOST HIT THE SALES REPRESENTATIVE SIX FEET AWAY. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(4) 2014, THE FOLLOWING WAS PROVIDED BY THE CUSTOMER (REGISTERED NURSE): ON (B)(6) 2014, A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A TRACHELECTOMY. THE PRODUCT PROBLEM (GOT VERY HOT) OCCURRED WHEN THE TUMOR WAS BEING REMOVED. THE PRODUCT WAS USED ON THE PATIENT. THERE WAS NO PATIENT OR USER HARM OR INJURY. THERE WAS NO REPLACEMENT PRODUCT AVAILABLE TO BE USED. THERE WAS NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271925 CUSA EXCEL 23KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES IRELAND LIMITED, SRAGH, TULLAMORE, CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR