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

Model Number SGS-E2S

Device Problems Nonstandard Device (1420); Overheating of Device (1437); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Injury (2348); Burn, Thermal (2530); Patient Problem/Medical Problem (2688)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Nakanishi is currently trying to obtain further information about the event and patient.

Event Description

On december 4, 2018, nakanishi received an e-mail from a distributor ((b)(4)) about a handpiece overheating.According to (b)(4), the information was provided through the adverse event questionnaire about the sgs/sga handpieces as a part of recall activities for those devices.The details are as follows.The event occurred in (b)(6) 2018.(the exact date is unknown).A dentist was performing a dental procedure using the sgs-e2s handpiece (serial no.(b)(4)).During the procedure, the handpiece overheated and burned a patient's lip.

Manufacturer Narrative

Nakanishi is still trying to obtain further information about the event and patient.Due to the device not being returned from the distributor, the only investigation nakanishi can make at this point is a dhr examination.As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.

Manufacturer Narrative

Nsk america (nam) took the following actions, but further information about the event was not provided.(b)(6) 2018, (b)(6) made a phone call to the dental office.(b)(6) 2018, (b)(6) sent an e-mail to the dentist.(b)(6) 2019, (b)(6) sent another e-mail to the dentist.

Manufacturer Narrative

On july 20, 2019, nakanishi was informed by nam that the following actions had been taken.- in november 2018 (exact date unknown), a distributor sent the updated operation manuals (provided to them by nam) that contain the detailed reprocessing method to the dental office to prevent the devices from overheating.- on december 5, 2018, nam confirmed the receipt of the operation manuals by the dentist via e-mail from the distributor.

• 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
• MDR Report Key: 8186543
• MDR Text Key: 131139820
• Report Number: 9611253-2018-00067
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• PMA/PMN Number: K171155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2018,08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2018
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/04/2018
• Date Manufacturer Received: 07/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 9611253-060818-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other