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

Model Number SGA-E2S

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017); Temperature Problem (3022)

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

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On march 2, 2018, nakanishi received documents from an attorney by post stating that an nsk handpiece had burned a patient.Details are as follows.The event occurred on (b)(6) 2017.A dentist was extracting the patient's wisdom teeth (teeth #1, 16 and 17) using the handpiece, sga-e2s (serial no.: (b)(4)).During the surgery, an iv sedation was administered to the patient.During the surgical procedure, the dentist rested the device on the left side of the patient's lower lip.The handpiece overheated, causing serious and permanent burn injury and scarring to the patient's lower lip and chin.

Manufacturer Narrative

On march 9, 2018, nakanishi received an e-mail from the distributor (b)(4) stating that there was neither information available about the patient nor the device returned from the customer for investigation.Due to the device not being returned from the distributor, (b)(4) (manufacturer) made the dhr examination as the investigation approach.As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.

• 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. REGISTRATION NUMBER : 9611253; mfr rpt# : 9611253-2018-00010; 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: 7363138
• MDR Text Key: 103232516
• Report Number: 9611253-2018-00010
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2018,07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: SGA-E2S
• Device Catalogue Number: H265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/20/2018
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 03/19/2018
• Date Manufacturer Received: 06/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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