MAUDE Adverse Event Report: NAKANISHI INC. NSK; SGS-E2S

Model Number SGS-E2S

Device Problems Inadequate Instructions for Healthcare Professional (1319); Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Peeling (1999); Burn, Thermal (2530); Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Event Description

On (b)(6) 2014, nsk american corp.Received a repair request from the dental office with the description/need for repair described as "burned pt.Lip." no additional information was provided.Nsk american corp.Contacted the dental office on (b)(6) 2014 in an attempt to gather additional information, specifically the condition of the patient and the action that was taken as a result of the alleged incident.The dental office provided the following information: age and sex of the patient ((b)(6) year old female); procedure being performed at the time of the alleged incident as the extraction of 4 wisdom teeth under general/local anesthesia; prior to the alleged incident, there were no indications that the device had malfunctioned or was not performing as intended; first indication of a potential injury was an observation of missing skin from the patient's lip.Further observation suggested the injury was a 2nd or 3rd degree burn.The patient was prescribed pain medication and oral antibiotics; the patient returned to the dental office the following week for a pre-scheduled follow-up; no additional treatment was needed at that time.The device was returned to (b)(4) (initial importer) on (b)(4) 2014 for "repair" per the customer's request.Initial visual inspection of the device indicates that the device was not properly maintained according to the instructions for use.A preliminary review of the labeling indicates additional clarification, warnings, and cautions may be needed.The report has been submitted to the original manufacturer.Clarification of date of the event, follow up appointment and additional information has been requested from the office.We attempted contact by phone twice, followed by two letters sent on 04/24/2014 and 04/29/2014.No response has been received.

• Brand Name: NSK
• Type of Device: SGS-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: 3889067
• MDR Text Key: 20784899
• Report Number: 1422375-2014-00001
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 05/09/2014,04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SGS-E2S
• Device Catalogue Number: H266
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2014
• Distributor Facility Aware Date: 04/09/2014
• Device Age: 10 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR