BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3974967 · Received June 12, 2014

    Report

    Report Number
    1219930-2014-00439
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV), CONCURRENTLY WITH ENGINEERING, LED AN EVALUATION OF ONE IDRIVE ULTRA POWERED HANDLE 1 OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, ENGINEERING ANALYSIS, AND AN EVALUATION OF THE RETURNED DEVICE. THE REPORTED CONDITION FOR THIS INCIDENT WAS THAT DURING A COLECTOMY PROCEDURE THE INSTRUMENT DID NOT FIRE. ENGINEERING EVALUATED THE EEPROM EVENT LOG FORM THE FIELD AND FOUND THAT UPON PRESSING THE GREEN SAFETY BUTTON, THE CODE ERR_OW_PROGRAM_PULSE WAS DISPLAYED THREE CONSECUTIVE TIMES. THIS WAS REPEATED ON SUBSEQUENT PRESSES OF THE GREEN SAFETY BUTTON. A VISUAL INSPECTION OF THE BATTERY CONTACTS WAS PERFORMED, AND NO SIGNS OF RESIDUE OR DAMAGE WERE NOTED. THE UNIT WAS THEN POWERED UP USING PRODUCTION BATTERY (B)(4). A KNOWN WORKING ADAPTER WAS ATTACHED AND SUCCESSFULLY COMPLETED CALIBRATION. A RELOAD WAS ATTACHED, AFTER WHICH IT WAS SUCCESSFULLY CLOSED, OPENED, AND CLOSED AGAIN, WITH THE STATUS INDICATOR LIGHTS ILLUMINATED GREEN. UPON PRESSING THE GREEN SAFETY BUTTON TO ENTER FIRE MODE, BLUE STATUS INDICATOR LIGHTS WERE SHOWN, INDICATING THE DEVICE WAS UNABLE TO ENTER FIRE MODE. THE EEPROM EVENT LOG WAS READ, AND THE ERR_OW_PROGRAM_PULSE CODE WAS DISPLAYED THREE CONSECUTIVE TIMES AFTER THE GREEN BUTTON PRESS, CONFIRMING THE REPORTED CONDITION SEEN IN THE FIELD AND PMV LAB. THE HANDLE WAS THEN POWERED UP WITH A SPECIALIZED BATTERY. THIS BATTERY HAS ALL THE COMPONENTS OF A PRODUCTION BATTERY, WITH THE EXCEPTION THAT THE ORIGINAL 1-WIRE CHIP WAS REMOVED AND REPLACED WITH A 1-WIRE CHIP THAT WAS PROGRAMMED SO THAT THE AUTOCLAVE/FIRING COUNTER ON THE HANDLE AND ADAPTER WOULD NOT BE INCREMENTED WHEN USED WITH THIS BATTERY. WHEN THE BATTERY WAS USED WITH THE HANDLE FROM THIS RETURN, IT WAS ABLE TO SUCCESSFULLY ENTER FIRE MODE AND COMPLETE A FIRING. THIS INDICATES THAT THE HANDLE IS FUNCTIONAL, EXCEPT FOR THE ABILITY TO INCREMENT THE AUTOCLAVE/FIRING COUNTERS. UPON EXAMINATION OF THE SOFTWARE, THE OW_PROGRAM_PULSE CODE IS ONLY DISPLAYED WHEN THE 1-WIRE BUS ON THE BLDC BOARD IS ATTEMPTING TO INCREMENT THE AUTOCLAVE/FIRING COUNTER ON THE ADAPTER, HOWEVER CANNOT SEND THE 12V PROGRAMMING PULSE NEEDED BECAUSE THE VOLTAGE IS UNAVAILABLE. THIS MEANS THAT THE ERROR IS WITHIN THE 1-WIRE BUS CIRCUIT OF THE BLDC BOARD. THE UNIT WAS TAKEN APART, AND THE BLDC BOARD WAS EXAMINED, AND THERE WERE NO WORKMANSHIP ISSUES WITH SOLDERING OR SIGNS OF ESD DAMAGE, AND ALL WIRE CONNECTIONS WERE INTACT. FROM THE TROUBLESHOOTING OF THE IDRIVE ULTRA, IT WAS DETERMINED THAT THE BLDC BOARD WAS RESPONSIBLE FOR THE REPORTED CONDITION, SPECIFICALLY THE 1-WIRE BUS CIRCUIT. THE 1-WIRE BUS CIRCUIT IS RESPONSIBLE FOR SENDING THE PROGRAMMING PULSE THAT INCREMENTS THE AUTOCLAVE AND FIRING COUNTER ON THE ADAPTER. INABILITY TO INCREMENT THESE COUNTERS WHEN THE GREEN SAFETY BUTTON IS PRESSED WILL PREVENT THE HANDLE FROM ENTERING FIRING MODE, LEADING TO THE REPORTED CONDITION SEEN IN THE FIELD. THE DEFECTIVE BLDC BOARD WILL BE SENT BACK TO OSI ELECTRONICS FOR FURTHER EVALUATION UNDER SUPPLIER NOTIFICATION (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY SPECIFICATIONS. THE REPORTED CONDITION WAS DETERMINED TO BE CAUSED BY A FAILURE OF THE BLDC BOARD. THE BOARD WILL BE SENT TO THE SUPPLIER FOR FURTHER INVESTIGATION. THIS FILE WILL BE TRACKED FOR CORRECTIVE ACTION. (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: VATS. ACCORDING TO THE REPORTER: RELOAD COULD NOT BE FIRED. INSTRUMENTS WAS LOADED CORRECTLY. AFTER PUSHING THE GREEN BUTTON AND PRESSING THE BLUE RELEASE BUTTON THE STATUS LIGHT WENT TO BLUE AND THE RELOAD COULD NOT BE FIRED. 3 DIFFERENT RELOADS WERE TESTED, AND SAME SITUATION OCCURRED. AFTER CHANGING THE HANDLE THE RELOADS COULD BE FIRED WITHOUT ANY PROBLEM. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346512 IDRIVE ULTRA POWERED HANDLE 1 STAPLE, IMPLANTABLE GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N2C0965UX

    Patients

    Seq Age Sex Outcome Treatment
    1