MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, ROTARY BONE CUTTING

Model Number SGS-E2S

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Date 11/19/2021

Event Type  Injury  

Event Description

Details are as follows: the event occurred on (b)(6) 2021.The dentist was extracting a wisdom tooth from the patient's lower left jaw using the sgs-e2s handpiece (serial no.: (b)(4)).The patient was under iv conscious sedation.During the procedure, the handpiece overheated and the patient received a burn injury on their lip.The dentist prescribed silvadene 1% cream for treatment of the injury.The patient is reported to be healing normally without further medical treatment.

Manufacturer Narrative

The same adverse event in this report has been reported to the fda separately by the distributor, (b)(4), under report number 1422375-2021-00033.

Manufacturer Narrative

The same adverse event in this report has been reported to the fda separately by the distributor, (b)(4), under report number 1422375-2021-00033.

Event Description

Details are as follows: the event occurred on (b)(6) 2021.The dentist was extracting a wisdom tooth from the patient's lower left jaw using the sgs-e2s handpiece (serial no.: (b)(4)).The patient was under iv conscious sedation.During the procedure, the handpiece overheated and the patient received a burn injury on their lip.The dentist prescribed silvadene 1% cream for treatment of the injury.The patient is reported to be healing normally without further medical treatment.

Manufacturer Narrative

Upon receiving the device involved in the mdr event from the distributor, nakanishi conducted a failure analysis of the returned device, which included measuring the operating temperature of the device [report no.(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 sgs-e2s device [serial no.(b)(6)].There were no problems observed during manufacturing or testing noted in the dhr.There were also no repair history records since the device was shipped.B) nakanishi conducted temperature testing of the returned device in the following manner: b.1) temperature sensors were attached to the exterior of the device at various test points.This included the point most proximal to the patient (testing point (1)) and points further toward the distal end of the device (testing points (2) through (4)).The test setup was prepared to take temperature measurements at all points simultaneously, including a reference measurement at ambient room temperature.B.2) nakanishi attached a thermocouple (sensor to measure temperature) to each of the testing points.Nakanishi rotated the device's motor at (b)(4), which is the maximum rpm for the motor that drives the handpiece ((b)(4) for the handpiece), with no water spray, and measured the exothermic response.B.3) nakanishi measured the temperature rise of the returned handpiece set at (b)(4) (motor revolution (b)(4)).Nakanishi observed an abnormal temperature rise at test points (1), (2), and (4) a few seconds into the test.Temperature measurements about 250 seconds after the start of the test were as follows: - test point (1): 76.0 degrees c.- test point (2): 52.7 degrees c.- test point (3): 50.8 degrees c.- test point (4): 59.3 degrees c.The increase in temperature was so sudden that the test was concluded about 250 seconds into the planned 5-minute evaluation period.Identification of the specific failure mode(s) and/or mechanism(s) of the associated device components was conducted as follows: a) nakanishi disassembled the handpiece and performed a visual inspection of the internal parts.Nakanishi observed that the bearing was discolored and soiled.B) nakanishi took photographs of all the disassembled parts and kept them in investigation report no.(b)(4).Conclusions reached based on the investigation and analysis results: a) nakanishi determined that the cause of the overheating of the returned device was abnormal resistance during rotation due to the abraded internal parts caused by the soiled internal parts.B) a lack of maintenance caused the accumulation of debris on the internal parts, which contributed to the handpiece overheating.C) in order to prevent a recurrence of the handpiece overheating, nakanishi took the following actions: c.1) nakanishi reviewed the operation manual and reconfirmed the clarity and understandability of the instructions.C.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.

• Brand Name: NSK
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: kenneth block ; 800 e campbell rd.; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 13058125
• MDR Text Key: 285651522
• Report Number: 9611253-2021-00072
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician Assistant
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGS-E2S
• Device Catalogue Number: H266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 9611253-060818-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White