NSK SGS-E2S H266001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-08-30 for NSK SGS-E2S H266001 manufactured by Nakanishi Inc..

Event Text Entries

[53558467] (b)(4). The information received from (b)(4) is as follows: the handpiece was sent in to (b)(4). The handpiece arrived at (b)(4) on august 10, 2016. There were no incoming comments indicating patient involvement. Repair history review was conducted on the handpiece sgs-e2s (serial number (b)(4)). The handpiece was at (b)(4) for repair on august 20, 2015 and june 14, 2016. An evaluation of the repair records on august 20, 2015 found that the handpiece had locked up due to heavy internal debris and corrosion. An evaluation of the repair records on june 14, 2016 found corrosion throughout internal system. On august 12, 2016, (b)(4) contacted the dental office to request additional patient information. The request for additional information was not made available to (b)(4). The dental office would not offer any further information in written or verbal communication.
Patient Sequence No: 1, Text Type: N, H10


[53558468] On august 15, 2016, nakanishi received an email from a distributor ((b)(4)) describing a burn to a patient. Details are as follows: on august 10, 2016, (b)(4) was made aware of an unconfirmed patient burn by a (b)(4) sales representative. The dentist stated that the handpiece had burnt a patient. (b)(4) forwarded the (b)(4) patient information form to the dentist to supply information on the experience. (b)(4) received the patient information form from the dentist on august 12, 2016 by email and details are as follows. The dentist stated that the burn was on the lip. The patient received a 1st and 2nd degree burn.
Patient Sequence No: 1, Text Type: D, B5


[62942256] Upon receiving the device involved in the adverse event, nakanishi conducted a failure analysis of the returned device: methodology used: a) nakanishi examined the device history record for the subject sgs-e2s device (serial number (b)(4)). There were no problems observed during the manufacturing or testing noted in the dhr. B) nakanishi conducted a visual inspection of the returned device and performed a simple movement test. - nakanishi set a test bur in the handpiece and rotated it by hand. Nakanishi observed a rotational resistance. - nakanishi did not observe any damage on the exterior. C) investigation of overheating: c. 1) temperature sensors were first attached to the exterior of the device at various test points (i. E. Most proximal to the patient, testing point (1), and along points further toward the distal end of the device, testing points (2) through (4)). The test was set up to take temperature measurements at all points simultaneously, including a reference measurement at ambient room temperature. C. 2) nakanishi attached a thermocouple (sensor to measure temperature) to each point. Nakanishi rotated the motor at 40,000 min-1, which is the maximum rpm for the motor that drives the handpiece (80,000 min-1 for the handpiece), and measured the exothermic situation. C. 3) nakanishi observed abnormal temperature rises at test points (1) and (2) 36 seconds after the start. Temperature measurements 36 seconds after the start are as follows: - test point (1): 64. 4 degrees c - test point (2): 79. 6 degrees c - test point (3): 36. 4 degrees c - test point (4): 45. 9 degrees c the temperature testing was conducted for 36 seconds into the planned 5 minute evaluation. C. 4) nakanishi washed the inside of the handpiece using nakanishi pana spray plus, as defined in the operation manual. Nakanishi observed dirt/debris being expelled from the head of the handpiece by using a white filter to catch anything that was expelled. C. 5) nakanishi measured the temperature rise of the handpiece cleaned using pana spray plus the way described in c. 1) and c. 2). Nakanishi still confirmed abnormal temperatures: 57. 5 degrees c and 68. 9 degrees c at test points (1) and (2) respectively. D) identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved: d. 1) nakanishi disassembled the handpiece and performed a visual inspection of the inside parts. Nakanishi observed that the bearings were broken and dirty. D. 2) nakanishi took photographs of all of the disassembled parts and kept them in a file. D. 3) nakanishi then replaced the bearings and measured the exothermic situation yet again. There was no abnormal rise in temperature during the test period. Nakanishi confirmed that the returned handpiece was operating as expected and within temperature specifications once the damaged bearings had been replaced. E) conclusion reached based on the investigation and analysis result: e. 1) nakanishi identified that the cause of the overheating of the returned device was abnormal resistance during rotation caused by the broken bearings. E. 2) a lack of maintenance causes the accumulation of dirt (abrasive powders/foreign materials) in the inside parts, which causes dirt/debris ingress into the bearing during rotation. This contributes to the handpiece overheating. E. 3) in order to prevent a recurrence of the handpiece overheating, nakanishi took the following actions: e. 3. 1) nakanishi reviewed the operation manual and reconfirmed clarity and understandability of the instructions. E. 3. 2) nakanishi reported the above evaluation results to nsk america and directed nsk america to remind the user of the importance of maintenance, as instructed in the operation manual.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9611253-2016-00049
MDR Report Key5915047
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2016-08-30
Date of Report2018-07-10
Date of Event2016-08-04
Date Facility Aware2016-08-10
Report Date2016-08-15
Date Reported to Mfgr2016-08-15
Date Mfgr Received2018-06-09
Device Manufacturer Date2013-10-30
Date Added to Maude2016-08-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR KENNETH BLOCK
Manufacturer Street800 E CAMPBELL RD. SUITE 202
Manufacturer CityRICHARDSON TX 75081
Manufacturer CountryUS
Manufacturer Postal75081
Manufacturer Phone9724809554
Manufacturer G1NAKANISHI INC. REGISTRATION NUMBER9611253
Manufacturer StreetMFR RP#:9611253-2016-00049 700 SHIMOHINATA
Manufacturer CityKANUMA-SHI, TOCHIGI-KEN 322-8666
Manufacturer CountryJA
Manufacturer Postal Code322-8666
Single Use3
Previous Use Code3
Removal Correction Number9611253-060818-001-R
Event Type3
Type of Report3

Device Details

Brand NameNSK
Generic NameHANDPIECE, ROTARY BONE CUTTING
Product CodeKMW
Date Received2016-08-30
Model NumberSGS-E2S
Catalog NumberH266001
OperatorDENTIST
Device AvailabilityY
Device Age3 YR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNAKANISHI INC.
Manufacturer Address700 SHIMOHINATA KANUMA-SHI, TOCHIGI-KEN 322-8666 JA 322-8666


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-08-30

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