MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, CONTRA AND RIGHT-ANGLE ATTACHMENT DENTAL

Model Number TI95EX

Device Problems Corroded (1131); Device Maintenance Issue (1379); Overheating of Device (1437); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 06/24/2014

Event Type  Injury  

Event Description

An nsk ex series handpiece, model ti95ex, was received for repair at nsk america on july 7, 2014.Enclosed with the handpiece was a business card for (b)(6), and a sterilization pouch on which was written "gets hot! under warranty".The initial mdr review performed by the nsk america qa manager on 07/08/2014 determined that the repair request was not reportable under mdr regulations.On july 11, 2014 (b)(6) called nsk america for an update on the handpiece repair and informed the nsk america employee that the handpiece had caused a burn on the patient during the wisdom tooth extraction.At the time of this notification, the handpiece had already been disassembled and an estimate for repair generated.Upon notification of a potential injury, nsk america qa manager contacted mr.(b)(6) by telephone on july 11, 2014 for additional information.Mr.(b)(6) did not have specific details of the event, but provided the contact information for the dental office.Nsk america qa manager spoke to (b)(6), dental assistant at the (b)(6), on july 11, 2014 who provided the information that was available to her.(b)(6) advised that she would call back with additional information once she had the opportunity to speak with the dentist, dr.(b)(6).No call back was received and so a letter from nsk america requesting the additional information was generated and sent to the dentist on july 12, 2014 by (b)(6) mail.Response to the july 12, 2014 letter request was received on july 25, 2014.It appears that the doctor sent the response but the respondent was not clearly identified.The details gathered during this process were: procedure being performed was a wisdom tooth extraction.Patient was under iv sedation at the time of the incident.Verbal report from (b)(6) on july 11, 2014 stated the initial indication of the malfunction was that the handpiece felt hot in the dentist's hand.The written correction stated that no abnormality or malfunction was observed.Verbal report stated that initial indication of injury was skin loss on inside of cheek.The written correction stated it was blistering.Verbal report stated the burn was 3rd degree.The written correction stated 1st and 2nd degree burns.Verbal report stated there was a fotrowrrp-dental appointment scheduled for (b)(6), 2014.The written report did not give any additional information regarding the patient's progress.Section for additional notes on the written response had the following comment: "i had no indication of abnormality until blistering was observed on cheek and tongue.At that point i felt the head of the handpiece and it was very hot to the touch." on july 11, 2014 nsk america qa manager performed a detailed inspection of the handpiece and found corrosion and debris on internal parts and in the bearings.It is likely that the corrosion and debris on internal parts added to the friction generated in the bearings and caused excess heat to form.Since this model of handpiece is operated by an electric motor, the handpiece will continue to rotate with the additional load, increasing the heat generated.Routine flushing and lubrication of the handpiece as outlined in the instructions for use will prevent this from occurring.Nsk america's initial investigation concluded that inadequate maintenance caused the failure.The handpiece was repaired under warranty by nsk america and returned to the dentist on july 21, 2014.Nsk america qa manager or support contacted the (b)(6) on august 1, 2014 and spoke to (b)(6) who informed nsk america that the patient had rescheduled his follow up appointment for (b)(6), 2014.Nsk america qa will contact the dentist to obtain additional information regarding the patient and this incident after the patient's scheduled visit on (b)(6), 2014.

• Brand Name: NSK
• Type of Device: HANDPIECE, CONTRA AND RIGHT-ANGLE ATTACHMENT DENTAL
• 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: 4199140
• MDR Text Key: 18931487
• Report Number: 1422375-2014-00007
• Device Sequence Number: 1
• Product Code: EGS
• 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: Dentist
• Type of Report: Initial
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: TI95EX
• Device Catalogue Number: C487
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2014
• Distributor Facility Aware Date: 07/11/2014
• Device Age: 9 YR
• Event Location: Other
• Date Report to Manufacturer: 07/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 59