BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK TI-MAX X95L

    MDR report key: 3823396 · Received April 25, 2014

    Report

    Report Number
    1422375-2014-00002
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 25, 2014
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, NSK AMERICA CORPORATION RECEIVED A TELEPHONIC COMPLAINT OF A HANDPIECE ALLEGEDLY CAUSING A BURN TO A PATIENT. THE EMPLOYEE CONTACTED COLLECTED THE FOLLOWING INFORMATION: "WORKING ON REMOVING DECAY OF NUMBER 30 AND 31. RAN HIGHSPEED APPROXIMATELY 1 MINUTE AFTER PAUSING FOR 5 MINUTES AT WHICH TIME A 1.5 INCH BURN WAS CREATED ON INSIDE CHEEK OF PATIENT. USES 6 YEAR OLD (B)(4) FOR LUBRICATION/MAINTENANCE AND STATIM FOR STERILIZATION. PATIENT SEEKING CARE OUTSIDE OF DENTIST AND MAY REQUIRE STITCHES." REPORT WAS FORWARDED TO QA ON (B)(4) 2014. QA ATTEMPTED TO CONTACT THE OFFICE TO ATTEMPT TO RETRIEVE HANDPIECE ON (B)(4) 2014 FOR ADDITIONAL REVIEW AND EVALUATION AND TO OBTAIN AN UPDATE ON THE STATUS OF PATIENT. CONTACT BY PHONE WAS ATTEMPTED ON 3 SEPARATE OCCASIONS ((B)(4)2014). A MESSAGE WAS LEFT ON THE ANSWERING MACHINE WITH CONTACT INFORMATION. OTHER EMPLOYEES OF NSK ALSO ATTEMPTED TO CONTACT THE OFFICE TO RETRIEVE THE HANDPIECE FOR REPAIR AND GAIN ADDITIONAL INFORMATION. AT THE TIME OF THIS REPORT ALL ATTEMPTS TO CONTACT HAVE BEEN UNSUCCESSFUL AND A LETTER HAS BEEN SENT TO THE COMPLAINANT TO DETERMINE THE CONDITION OF THE PATIENT AND EXTENT OF THE INJURY. HANDPIECE WAS SOLD AND SHIPPED TO DISTRIBUTOR ON (B)(4) 2012. PRELIMINARY REVIEW OF LABELING SHOWS ADEQUATE MAINTENANCE INSTRUCTIONS AND PRECAUTIONS TO PREVENT INJURIES TO PATIENTS ARE CLEARLY LISTED. IT IS NOT KNOWN WHETHER THE (B)(4) MAINTENANCE MACHINE, WHICH IS NOT VALIDATED OR APPROVED FOR USE BY NSK, ADEQUATELY LUBRICATES AND CLEANS THE PRODUCT. INSPECTION OF THE PRODUCT WOULD REVEAL WHETHER MAINTENANCE WAS A FACTOR IN THIS EVENT. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250475 NSK TI-MAX X95L DENTAL HANDPIECE EGS NAKANISHI INC. X95L

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention