• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Model Number M500L
Device Problems Detachment Of Device Component (1104); Unintended Ejection (1234); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problems Injury (2348); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Event Date 04/04/2017
Event Type  Injury  
Manufacturer Narrative
Upon receiving the device involved in the mdr event from a distributor, nakanishi conducted a failure analysis of the returned device [(b)(4)]. These activities are described in more detail below. Methodology used: a) nakanishi examined the device history record and the repair history for the subject s-max m500l device [serial number (b)(4)]. There were no problems observed during the manufacturing or testing noted in the dhr. There were no records indicating nakanishi (the manufacturer) repaired the device since the device was shipped. Nakanishi received the repair records from (b)(4), which included the detailed information about the repair (b)(4) carried out, along with the repair test results that indicate the repaired device passed every test item. Nakanishi kept the test results in a file. B) nakanishi conducted a visual inspection of the returned device and observed numerous dents and cracks on the outside of the handpiece. C) nakanishi then disassembled the handpiece and found that a counterfeit nsk cartridge was incorporated in the handpiece. Nakanishi determined the cartridge was not an nsk product are due to the following conditions: - there is no dust-proof disc on the bur insertion side of the cartridge. - the cartridge bears marking that the nsk cartridge does not have. D) nakanishi took photographs of the counterfeit nsk cartridge and kept them in a file. Conclusions reached based on the investigation and analysis results: 1) nakanishi identified that the cause of the bur coming off was the use of the counterfeit nsk cartridge by the operator. 2) failure to follow the instructions regarding cartridges compatible for use with the handpiece when replacing the cartridge contribute to the reported bur coming off. 3) in order to prevent a recurrence of the bur coming off, nakanishi took the following actions: 3. 1) nakanishi reviewed the operation manual and reconfirmed clarity and understandability of the instructions. 3. 2) nakanishi reported the above evaluation results to nsk america and directed nsk america to remind the user of the importance of following instructions in the operation manual and to explain how to avoid counterfeits.
Manufacturer Narrative
(b)(4). The information received from (b)(4) is as follows. - on april 4, 2017, (b)(4) received an email from the dental office explaining all three devices were forwarded to the dealer prior to the initial reporting of the unconfirmed event to (b)(4) and was to be serviced by the dealer. - the dealer was contacted by the dental office manager upon receiving (b)(4) request to forward the device to (b)(4) and per the dental office manager. - the dealer forwarded the device directly to (b)(4). - on april 6, 2017, april 10, 2017, and april 11, 2017, (b)(4) contacted the dental office by phone and email to request patient information, but the dental office did not disclose the patient information. - a service history record was found for model m500l (serial (b)(4)) at (b)(4) dated april 6, 2015. Nakanishi is submitting three separate mdrs for this event because the dentist referenced three devices that is a possibility that was in use at the time of the event. This mdr is related with mfr report #9611253-2017-00023 and mfr report #9611253-2017-00024 in describing event or problem.
Event Description
On april 14, 2017, nakanishi received an email from a distributor ((b)(4)) describing a patient injury. Details are as follows. - on april 4, 2017, (b)(4) was made aware of an unconfirmed patient injury by an nsk sales representative. - the dentist contacted the (b)(4) sales representative. - the dentist stated that a bur ejected from a handpiece device and the patient ingested the bur. - the event occurred on (b)(6) 2017. - the dentist also reported the device involved was not segregated at the time of the event and was placed back in stock by the dentist. - the device involved with patient can not be identified. - the dentist referenced three devices that were potentially in use at the time of the event and provided model number(s) and serial number(s) for each device as follows. M500l (serial (b)(4)). M500l (serial (b)(4)). M600l (serial (b)(4)). - (b)(4) contacted the dental office to obtain more information, and the (b)(4) patient information form was immediately forwarded to the dentist to be completed.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNSK
Manufacturer (Section D)
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA 322-8666
Manufacturer (Section G)
mfr rp#9611253-2017-00022
700 shimohinata
kanuma-shi, tochigi-ken 322-8 666
JA 322-8666
Manufacturer Contact
kenneth block
1201 richardson dr.
suite 160
richardson, TX 75080
MDR Report Key6541270
MDR Text Key196859679
Report Number9611253-2017-00022
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 04/12/2017,07/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Model NumberM500L
Device Catalogue NumberP1001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/04/2017
Device Age5 YR
Event Location Other
Date Report to Manufacturer04/12/2017
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/03/2017 Patient Sequence Number: 1