MAUDE Adverse Event Report: NAKANISHI INC. NSK SGA-E2S

Model Number SGA-E2S

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Type  malfunction  

Event Description

On (b)(6) 2015 nsk america received a handpiece (model sga-e2s serial number (b)(4)) from dealer for repair.Incoming comments stated "over heating burnt patient lip".Immediately contacted dealer for doctor information.Contacted office manager at dr.Office, received call back from manager.During conversation it was stated the doctor had burned two patients, on two consecutive days with the same handpiece.No information provided on patients or date of the event.Attempted contact by telephone and email on (b)(6) 2015, (b)(6) 2015 and (b)(6) 2015 no response and further follow-up's with no response.On (b)(6) 2015 received email response from manager stating office was closed for vacation.In addition, stated the doctor who is involved only comes into the office one time per month no information will be provided until he is available.(b)(6) 2015 handpiece replaced and forwarded to nhq for full evaluation.On (b)(6) 2015 no response to telephone attempt.

• Brand Name: NSK SGA-E2S
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322- 8666; JA 322-8666
• Manufacturer (Section G): NSK AMERICA CORP.; 700-b cooper ct.; schaumburg IL 60173
• Manufacturer Contact: 700-b cooper ct.; schaumburg, IL 60173
• MDR Report Key: 4892371
• MDR Text Key: 15356651
• Report Number: 1422375-2015-00011
• Device Sequence Number: 1
• Product Code: KMW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SGA-E2S
• Device Catalogue Number: H265
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/04/2015
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 06/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other