BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK TI95EX

    MDR report key: 5633810 · Received May 5, 2016

    Report

    Report Number
    9611253-2014-00007
    Event Type
    Injury
    Date Received
    May 5, 2016
    Date of Event
    June 24, 2014
    Report Date
    May 5, 2016
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (IMPORTER) EVALUATED THE DEVICE (TI95EX) AND CONCLUDED THAT INADEQUATE MAINTENANCE CAUSED THE REPORTED FAILURE. THE HAND PIECE WAS UNDER WARRANTY THEREFORE THE DEVICE WAS REPAIRED AND RETURNED TO THE DENTIST. THEREFORE AS AN INVESTIGATIONAL APPROACH NAKANISHI INC., (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR DEVICE (TI95EX, SERIAL NO. (B)(4)). NAKANISHI INC. CONCLUDED THAT NO PROBLEMS HAD OCCURRED DURING MANUFACTURING OR TESTING OF THE SUBJECT DEVICE, AS EVIDENCED IN THE DHR. NAKANISHI CONDUCTED A REVIEW OF THE FDA MAUDE DATABASE AND WAS UNABLE TO LOCATE REPORT 9611253-2014-00007 (THIS REPORT). NAKANISHI BELIEVES THIS REPORT TO HAVE BEEN SUBMITTED PREVIOUSLY; HOWEVER NAKANISHI IS RE-SUBMITTING THIS REPORT TO ENSURE THAT FDA HAS A RECORD OF THE REPORT IN THE MAUDE DATABASE. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    AN NSK EX SERIES HANDPIECE, MODEL TI95EX, WAS RECEIVED FOR REPAIR AT (B)(4) ON (B)(6) 2014. ENCLOSED WITH THE HANDPIECE WAS A BUSINESS CARD FROM (B)(4) OF PRECISION DENTAL REPAIR IN (B)(4), AND A STERILIZATION POUCH, ON WHICH WAS WRITTEN "GETS HOT! UNDER WARRANTY". THE INITIAL MDR REVIEW PERFORMED BY THE (B)(4) QA MANAGER ON 07/08/2014 DETERMINED THAT THE REPAIR REQUEST WAS NOT REPORTABLE UNDER MDR REGULATIONS. ON (B)(6) 2014 (B)(4) CALLED (B)(4) FOR AN UPDATE ON THE HANDPIECE REPAIR AND INFORMED THE (B)(4) EMPLOYEE THAT THE HANDPIECE HAD CAUSED A BURN ON THE PATIENT DURING THE WISDOM TOOTH EXTRACTION. AT THE TIME OF THIS NOTIFICATION, THE HANDPIECE HAD ALREADY BEEN DISASSEMBLED AND AN ESTIMATE FOR REPAIR GENERATED. UPON NOTIFICATION OF A POTENTIAL INJURY, (B)(4) QA MANAGER CONTACTED MR. (B)(4) BY TELEPHONE ON (B)(6) 2014 FOR ADDITIONAL INFORMATION. MR. (B)(4) DID NOT HAVE SPECIFIC DETAILS OF THE EVENT, BUT PROVIDED THE CONTACT INFORMATION FOR THE DENTAL OFFICE. (B)(4) QA MANAGER SPOKE TO (B)(6), DENTAL ASSISTANT AT THE (B)(6), ON (B)(6) 2014 WHO PROVIDED THE INFORMATION THAT WAS AVAILABLE TO HER. (B)(6) ADVISED THAT SHE WOULD CALL BACK WITH ADDITIONAL INFORMATION ONCE SHE HAD THE OPPORTUNITY TO SPEAK WITH THE DENTIST, DR. (B)(6), DDS. NO CALL BACK WAS RECEIVED AND SO A LETTER FROM (B)(4) REQUESTING THE ADDITIONAL INFORMATION WAS GENERATED AND SENT TO THE DENTIST ON (B)(6) 2014 BY US MAIL. RESPONSE TO THE (B)(6) 2014 LETTER REQUEST WAS RECEIVED ON (B)(6) 2014. IT APPEARS THAT THE DOCTOR SENT THE RESPONSE BUT THE RESPONDENT WAS NOT CLEARLY IDENTIFIED. THE DETAILS GATHERED DURING THIS PROCESS WERE: PROCEDURE BEING PERFORMED WAS A WISDOM TOOTH EXTRACTION. PATIENT WAS UNDER IV SEDATION AT THE TIME OF THE INCIDENT. VERBAL REPORT FROM (B)(6) ON (B)(6) 2014 STATED THE INITIAL INDICATION OF THE MALFUNCTION WAS THAT THE HANDPIECE FELT HOT IN THE DENTIST'S HAND. THE WRITTEN CORRECTION STATED THAT NO ABNORMALITY OR MALFUNCTION WAS OBSERVED. VERBAL REPORT STATED THAT INITIAL INDICATION OF INJURY WAS SKIN LOSS ON INSIDE OF CHEEK. THE WRITTEN CORRECTION STATED IT WAS BLISTERING. VERBAL REPORT STATED THE BURN WAS 3RD DEGREE. THE WRITTEN CORRECTION STATED 1ST AND 2ND DEGREE BURNS. VERBAL REPORT STATED THERE WAS A FOLLOW UP DENTAL APPOINTMENT SCHEDULED FOR (B)(6) 2014. THE WRITTEN REPORT DID NOT GIVE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT'S PROGRESS. THE SECTION FOR ADDITIONAL NOTES ON THE WRITTEN RESPONSE HAD THE FOLLOWING COMMENT: "I HAD NO INDICATION OF ABNORMALITY UNTIL BLISTERING WAS OBSERVED ON CHEEK AND TONGUE. AT THAT POINT I FELT THE HEAD OF THE HANDPIECE AND IT WAS VERY HOT TO THE TOUCH." ON JULY 11, 2014 (B)(4) QA MANAGER PERFORMED A DETAILED INSPECTION OF THE HANDPIECE AND FOUND CORROSION AND DEBRIS ON INTERNAL PARTS AND IN THE BEARINGS. IT IS LIKELY THAT THE CORROSION AND DEBRIS ON INTERNAL PARTS ADDED TO THE FRICTION GENERATED IN THE BEARINGS AND CAUSED EXCESS HEAT TO FORM. SINCE THIS MODEL OF HANDPIECE IS OPERATED BY AN ELECTRIC MOTOR, THE HANDPIECE WILL CONTINUE TO ROTATE WITH THE ADDITIONAL LOAD, INCREASING THE HEAT GENERATED. ROUTINE FLUSHING AND LUBRICATION OF THE HANDPIECE AS OUTLINED IN THE INSTRUCTIONS FOR USE WILL PREVENT THIS FROM OCCURRING. (B)(4) INITIAL INVESTIGATION CONCLUDED THAT INADEQUATE MAINTENANCE CAUSED THE FAILURE. THE HANDPIECE WAS REPAIRED UNDER WARRANTY BY (B)(4) AND RETURNED TO THE DENTIST ON JULY 21, 2014. (B)(4) QA MANAGER OR SUPPORT CONTACTED THE (B)(6) ON (B)(6) 2014 AND SPOKE TO (B)(6) WHO INFORMED (B)(4) THAT THE PATIENT HAD RESCHEDULED HIS FOLLOW UP APPOINTMENT FOR (B)(6) 2014. (B)(4) QA WILL CONTACT THE DENTIST TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT AND THIS INCIDENT AFTER THE PATIENT'S SCHEDULED VISIT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289050 NSK TI95EX HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. TI95EX

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention