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

Model Number SGA-E2S

Device Problems Overheating of Device (1437); Physical Property Issue (3008); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 06/17/2016

Event Type  Injury  

Manufacturer Narrative

Since the patient weight was not included in the information about the adverse event, nakanishi received from the distributor on june 19, 2016, nakanishi sent the distributor an email for the information about the patient weight on (b)(6) 2016.According to the distributor, the dentist refused to provide the information.Due to the device not being returned from the distributor, an examination of the dhr for device (h265 sga-e2s 1:2 20 degree angle, serial no.(b)(4)) is the only investigation approach nakanishi inc., (b)(4) (manufacturer) can make.As a result of the examination, the dhr indicated that no problems had occurred during manufacturing and testing of the subject device.

Event Description

On june 19, 2016, nakanishi received an email from a distributor ((b)(4)) stating that a patient was burned due to a handpiece overheating.Details are as follows.The event occurred on (b)(6) 2016.The dentist was sectioning a tooth during the extraction of wisdom teeth.The dentist was aware of the unit overheating during the procedure and found the handpiece had burned the inside of the patient's mouth.According to the dentist, the damage is a possible 2nd degree burn.The dentist applied burn ointment to the burn injury in the patient's mouth.When the patient visited the dental office on (b)(6) 2016, the dentist confirmed that the injury was still healing and was not expected to leave any permanent damage.

• 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: 5852921
• MDR Text Key: 51341181
• Report Number: 9611253-2016-00040
• 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: distributor
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• 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?: Yes
• Date Manufacturer Received: 06/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2012
• 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: 20 YR