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

Model Number SGS-E2S

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 10/04/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 the doctor was performing a wisdom tooth extraction with the patient under moderate sedation when the handpiece he was using heated up and caused a burn to the patient's lip.The doctor treated the injury site with vaseline and no further medical treatment was reported to be required.

• Brand Name: NSK
• Type of Device: SURGICAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, 322-8 666; JA 322-8666
• MDR Report Key: 9358999
• MDR Text Key: 179611480
• Report Number: 1422375-2019-00019
• Device Sequence Number: 1
• Product Code: KMW
• UDI-Device Identifier: 04560264556294
• UDI-Public: 04560264556294
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SGS-E2S
• Device Catalogue Number: H266001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2019
• Distributor Facility Aware Date: 11/01/2019
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/21/2019
• 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: 27 YR
• Patient Weight: 95