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

Model Number SGA-E2S

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

Patient Problems Burn(s) (1757); Injury (2348); Burn, Thermal (2530)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On december 5, 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) 2015.(the exact date is unknown).A dentist was performing a dental procedure using the sga-e2s handpiece (serial no.Unknown).During the procedure, the handpiece overheated and burned a patient's lip.

Manufacturer Narrative

Nsk america (nam) took the following actions, but further information about the event and patient was not provided by the dentist.- on december 14, 2018, nam made a phone call to the dental office and left a message.- on january 29, 2019, nam made another phone call to the dentist and left a message.- on may 28, 2019, nam sent an e-mail to the dentist.

• 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: 8186538
• MDR Text Key: 131143951
• Report Number: 9611253-2018-00069
• 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
• Report Date: 12/05/2018,07/10/2019

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: SGA-E2S
• Device Catalogue Number: H265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/05/2018
• Date Manufacturer Received: 06/13/2019
• 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