MAUDE Adverse Event Report: NAKANISHI INC. NSK SGA-E2G; SURGICAL HANDPIECE

Model Number SGA-E2G

Device Problems 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); Tissue Damage (2104); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 04/23/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 nsk america corp.Received a telephonic complaint of a handpiece allegedly causing a burn to a patient.The employee collected the following information: "on second use after repair handpiece heated up and caused a 2nd degree burn.Handpiece worked fine on initial use.Injury occurred during extraction of all 4 wisdom teeth.Patient was on nitrous with local anesthetic.No indications of failure prior to patient being burned.First (indication) of injury was burn on inner portion of lip.Blistering and loss of skin was observed.Patient given antibiotics, pain medication, steroid and salve for burn healing and pain relief.Patient scheduled for follow up on (b)(6) 2014." investigation of the repair concluded that the repair was performed by nsk america corp.Technician on (b)(6) 2014 in accordance with procedures and documentation available.Upon notification of manufacturer it was found that a bearing used in the repair of this product has been redesigned and initial notification was sent to nsk america, however, notification of the availability and implementation of the bearing was never received.A corrective action was initiated to quarantine and replace the bearings in nsk america's inventory and to recommend review of procedures for dissemination of information regarding material changes from the manufacturer.Handpiece received at nsk america on (b)(4) 2014, initial inspection showed that inadequate maintenance practices may have played a part in the failure of the device.Surgical debris was observed in the nose of the handpiece at the location that caused the burn.Device was forwarded to manufacturer on (b)(4) 2014 for further inspection and investigation and a new (b)(6) 2014.Dr.Reported patient's injury was about 30% healed.First indication of failure observed by the doctor was feeling the handpiece getting hot and seeing his glove melting.As of (b)(6) 2013 no additional information has been received.

• Brand Name: NSK SGA-E2G
• Type of Device: SURGICAL HANDPIECE
• 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: 3888666
• MDR Text Key: 17275156
• Report Number: 1422375-2014-00003
• 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: Dentist
• Type of Report: Initial
• Report Date: 05/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SGA-E2G
• Device Catalogue Number: H184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2014
• Distributor Facility Aware Date: 04/23/2014
• Device Age: 7 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 86