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

Model Number X-SG65L

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

Nakanishi is still trying to obtain information about the event, including information about the patient.

Event Description

On march 14, 2023, nakanishi received an email from a distributor (nsk europe) about a nsk handpiece overheating.The details are as follows: the event occurred around (b)(6) 2023.(the exact date is unknown.) the dentist was performing a dental procedure of a patient using the x-sg65l (serial no.(b)(4)).During the procedure, the end of the handpiece suddenly became hot, and the patient received a rather severe burn to their lip.The burn was discovered relatively quickly but it was already too late.

Manufacturer Narrative

The dentist refused to provide information about the patient's weight.According to the distributor (nsk nordic), further inspection of the handpiece involved in the adverse event for cause by nakanishi is no longer possible because the handpiece was serviced by the distributor and returned to the user.Due to the device not being returned from the distributor, nakanishi examined the device history record (dhr) for the subject x-sg65l device [serial no.(b)(6)].As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.

Event Description

On april 27, 2023, nakanishi received detailed information on the event from the distributor (nsk nordic).At the time of the event, the dentist was performing a removal procedure on a wisdom tooth of a patient.The patient was under standard anesthesia.The dentist felt that the handpiece was warm and found a burn to their lip.The patient was prescribed an anti-inflammatory cream.The patient has had a check-up with the dentist on two occasions and the injury was not completely healed, still red in the area and was expected to be possible scarring.The patient may need for surgical correction by a plastic surgeon if the injury does not complete healing.

• 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: sean kaufman ; 1800 global parkway; hoffman estates, IL 60192 ; 2245128921
• MDR Report Key: 16705328
• MDR Text Key: 312940299
• Report Number: 9611253-2023-00021
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K970953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-SG65L
• Device Catalogue Number: H1009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White