BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT PEDAL FOR PIEZOELECTRIC SYSTEM

    MDR report key: 5051166 · Received September 2, 2015

    Report

    Report Number
    2520274-2015-15651
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 21, 2015
    Report Date
    August 21, 2015
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    JDX
    PMA / PMN Number
    PK100410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT OR SERIAL NUMBER, A SERVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A SERVICE & REPAIR HISTORY REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT THE: SERVICE HISTORY REVIEW: PART NO: 05.001.402, SERIAL/LOT NO: (B)(4). A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE MANUFACTURE DATE OF THIS ITEM IS 26-JUL-2011. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE AND REPAIR EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE CUSTOMER REPORTED THE FOOT PEDAL WAS RUNNING CONTINUOUSLY. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WAS SENT TO THE VENDOR FOR REPAIR ON 15-OCT-2015. THE VENDOR DETERMINED THAT THE FOOT PEDAL HAD AN INTERNAL ISSUE, WHICH REQUIRED REPLACEMENT OF THE DEVICE. THE ITEM WAS BE FORWARDED TO THE SYNTHES COMPLAINT HANDLING UNIT (CHU) UPON COMPLETION OF SERVICE AND REPAIR PROCESS FOR ADDITIONAL EVALUATION. THE EVALUATION WAS CONFIRMED. ADDITIONAL INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE BY THE SYNTHES CHU. THE FOOT PEDAL (05.001.402 LOT 700780.021) IS A COMPONENT OF THE PIEZOELECTRIC SYSTEM SET (01.001.598) AND PROVIDES REAL-TIME HANDS-FREE ADJUSTMENT OF THE HANDPIECE DURING SURGERY PER THE TECHNIQUE GUIDE. THE FOOT PEDAL IS COMPRISED OF FIVE BUTTONS, EACH OF WHICH PERFORMS DIFFERENCE FUNCTIONS: HANDPIECE CONTROL, FLUSH/PRIME IRRIGATION, CHANGE PROGRAM, SELECT LEFT OR RIGHT HANDPIECE, IRRIGATION ON/OFF. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; THE FAILURE MODE IS LIKELY RELATED TO ROUGH HANDLING AND/OR WEAR OVER 4+ YEARS OF USE (MANUFACTURING DATE JUNE 2011). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE SERVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOOT PEDAL WILL NOT STOP RUNNING UNLESS IT IS UNPLUGGED AND PLUGGED BACK IN AGAIN. THE HAND PIECE READS AS "NO DETECTED" ON THE CONSOLE. THE COMPLAINED ISSUED OCCURRED HAPPENED INTRAOPERATIVELY; HOWEVER, THE DEVICE WAS NOT USED ON THE PATIENT AND THERE WAS NO SURGICAL DELAY. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580551 FOOT PEDAL FOR PIEZOELECTRIC SYSTEM INSTRUMENT, SURGICAL, SONIC ACCESSORY, ATTACHMENT JDX SYNTHES OBERDORF 700780.021

    Patients

    Seq Age Sex Outcome Treatment
    1