MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-08-10 for NSK X-SG65L H1009 manufactured by Nakanishi, Inc..
[23402083]
On (b)(6) 2015, nakanishi received a phone call from a distributor saying that a dentist had burned a pt due to overheating of an nsk handpiece, ti-max x-sg65l. Details are as follows: the event occurred on (b)(6) 2015. The pt is male. The pt was burned on the upper left in a mouth.
Patient Sequence No: 1, Text Type: D, B5
[27016584]
Upon receipt of the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device that included measurement of the temperature of the operating device [(b)(4)]. These activities are described in more detail below. Methodology used : a) nakanishi examined the device history record for the subject ti-max x-sg65l device [serial number (b)(4)]. There were no problems observed during the manufacturing or testing noted in the dhr. B) nakanishi performed a simple movement test of the returned device. Nakanishi set a test bur in the handpiece and rotate it by hand to see bearing condition. Nakanishi observed that the bur did not rotate at all. C) nakanishi then cleaned the inside of the handpiece using nakanishi pana-spray to perform the temperature measurement. Nakanishi observed dirt being expelled from the handpiece. After cleaning the handpiece, the test bur rotated, but it was not smooth rotation. D) nakanishi conducted a temperature testing of the returned device in the following manner. D. 1) temperature sensors were first attached to the exterior of the device at various test points (e. G. , most proximal to the patient and along points further toward the distal end of the device). The test setup was prepared to take temperature measurements at all points simultaneously, including a reference measurement at ambient room temperature. D. 2) nakanishi attached a thermocouple (sensor to measure a temperature) to each of the testing points (1), (2), (3) and (4). Nakanishi rotated the handpiece at 40,000 rpm, which is maximum rpm for the motor that drives the handpiece (40,000 prm for the handpiece), with water spray and measured the exothermic situation. D. 3) nakanishi measured the temperature rise of the returned handpiece set at 40,000 rpm (motor revolution 40,000rpm). Nakanishi confirmed the following temperature rise at the test points after the beginning of the measurement ; (1) 45. 3 degrees c, (2) 48. 6 degrees c, (3) 45. 2 degrees c and (4) 42. 8 degrees c. All the temperatures observed in the measurement were within the nakanishi specification range, however, the temperatures were relatively high compared to the temperatures observed in the normally operable x-sg65l. Identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved : a) nakanishi disassembled the handpiece and performed a visual inspection of the inside parts. Nakanishi observed corrosion of almost every inner parts including the bearing. B) nakanishi took photographs of all the corroded parts mentioned above and kept them in a file. Conclusions reached based on the investigation and analysis results : 1) nakanishi identified that the cause of overheating of the returned device was due to corrosion of the inner parts. 2) a lack of maintenance generates corrosion of inner parts, which causes abnormal rotation resistance. This will contribute to the handpiece overheating. 3) in order to prevent a recurrence of the handpiece overheating, nakanishi took the following actions. 3. 1) nakanishi first reviewed the operation manual and ensured clarity, understandability and feasibility of the instructions. 3. 2) nakanishi reported the above evaluation results to the dentist and reminded the dentist of the importance of maintenance and prior-to-use checkups as instructed in the operation manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611253-2015-00105 |
| MDR Report Key | 4992131 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-08-10 |
| Date of Report | 2015-07-30 |
| Date of Event | 2015-07-29 |
| Date Mfgr Received | 2015-07-30 |
| Device Manufacturer Date | 2013-02-25 |
| Date Added to Maude | 2015-08-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KEN BLOCK |
| Manufacturer Street | 1201 RICHARDSON DR. STE 280 |
| Manufacturer City | RICHARDSON TX 75080 |
| Manufacturer Country | US |
| Manufacturer Postal | 75080 |
| Manufacturer Phone | 9724809544 |
| Manufacturer G1 | NAKANISHI, INC. |
| Manufacturer Street | 700 SHIMOHINATA |
| Manufacturer City | KANUMA-SHI, TOCHIGI-KEN 322-8666 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 322-8666 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NSK |
| Generic Name | HANDPIECE, ROTARY BONE CUTTING |
| Product Code | KMW |
| Date Received | 2015-08-10 |
| Returned To Mfg | 2015-08-04 |
| Model Number | X-SG65L |
| Catalog Number | H1009 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAKANISHI, INC. |
| Manufacturer Address | 700 SHIMOHINATA KANUMA-SHI, TOCHIGI-KEN 322-8666 JA 322-8666 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-10 |