BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR PIEZOELECTRIC SYSTEM

    MDR report key: 4841413 · Received June 12, 2015

    Report

    Report Number
    2520274-2015-14426
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    ERL
    PMA / PMN Number
    PK100410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. CORRECTED STATEMENT ¿THERE ARE 3 PARTS TO THIS COMPLAINT.¿ TO ¿THIS IS REPORT 1 OF 1 FOR (B)(4).¿ 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: JDX, DZI, HBE, HWE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 AND REPAIR EVALUATION WAS PERFORMED: THE CUSTOMER REPORTED THE DRILL WAS BEGINNING TO SMOKE DURING A PROCEDURE. THE REPAIR TECHNICIAN REPORTED THE HAND PIECE WAS MISSING THE LIGHT DIFFUSER. MISSING PARTS IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WAS SENT TO THE VENDOR FOR REPAIR ON 7-JUL-2015. THIS ITEM PASSED SYNTHES FINAL INSPECTION ON 1-SEP-2015 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS CONFIRMED. 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 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

    A SERVICE & REPAIR HISTORY MAINTENANCE REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT THE SERVICE HISTORY REVIEW: (UPDATED LOT # 203966.004) A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON 24-JUL-2012, 20-AUG-2012, 3-OCT-2012, 10-JAN-2013, 7-MAR-2013, 24-APR-2013, 1-AUG-2013 AND 20-AUG-2013 AND THE DEVICE PASSED TESTING. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON 29-MAY-2015 AND REPORTED THAT THE DEVICE IS INOPERABLE-BEGAN TO SMOKE. THE PREVIOUS SERVICE CONDITIONS OF DEVICE PASSED TESTING ARE NOT RELEVANT TO THE CURRENT COMPLAINED ISSUE OF THE DEVICE IS INOPERABLE-BEGAN TO SMOKE. THE MANUFACTURE DATE OF THIS ITEM IS 13-JAN-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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 AN ULTRASONIC DRILL HAND PIECE FROM AN ELECTRIC PEN DRIVE SET BEGAN TO SMOKE DURING A PROCEDURE. THERE ARE 3 PARTS TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385259 HAND PIECE FOR PIEZOELECTRIC SYSTEM INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT ERL SYNTHES OBERDORF 203966.004

    Patients

    Seq Age Sex Outcome Treatment
    1