MAUDE Adverse Event Report: NAKANISHI INC. MICRO SURGERY HANDPIECE; DENTAL HANDPIECE

Model Number SGS-E2S

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/02/2021

Event Type  Injury  

Event Description

Patient received a second degree burn injury to their lower lip during a third molar extraction procedure on teeth numbers 1, 16, 17, 32.The doctor did not note any heat from the device during the procedure, the abnormal heating of the device was only noted after blistering had been observed on the patient's lip.The patient is reported to be healing normally without need for additional medical treatment at this time.Device has been removed from use at the practice and is being held by doctor at this time in relation to possible patient claim.Device will be sent to manufacturer once doctor has cleared any need in relation to patient claim.

• Brand Name: MICRO SURGERY HANDPIECE
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma, tochigi 322-8 666; JA 322-8666
• MDR Report Key: 12387880
• MDR Text Key: 268803886
• Report Number: 1422375-2021-00021
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/30/2021,08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGS-E2S
• Device Catalogue Number: H266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2021
• Distributor Facility Aware Date: 08/04/2021
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR