MAUDE Adverse Event Report: NAKANISHI INC. FORZA F5; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Model Number FORZA F5

Device Problems Overheating of Device (1437); Physical Property Issue (3008); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

Nakanishi did not receive information about the patient weight.Nakanishi will try to contact the distributor again for the information.Due to the device not being returned from the distributor, (b)(4) (manufacturer) made the dhr examination as the investigation approach.As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.

Event Description

On (b)(6) 2018, nakanishi received an email from a distributor ((b)(4)) about an nsk handpiece overheating.According to the distributor, one of the forza f5 handpieces (serial no.(b)(4)) overheated and caused the following event, but the dentist could not identify which devices actually overheated.The details of the event are: the event occurred on (b)(6) 2018.The dentist was providing a patient with a crown preparation using the forza f5.During the procedure, the handpiece overheated and burned the patient.The dentist found a burn injury about the size of the handpiece head inside the patient's cheek.No burn treatment was required, but the dentist recommended that the patient rinse with salt water or use medicated salve, if needed.The patient was scheduled to return to the office on (b)(6) 2018 for follow-up.Nakanishi is submitting two separate mdrs for this event based on the information from the distributor.This mdr is regarding the handpiece with the serial number (b)(4).

Manufacturer Narrative

On june 2, 2018, nakanishi received an e-mail from the distributor stating that the distributor was not able to obtain information about the patient's weight, ethnicity and race.

• Brand Name: FORZA F5
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 7536534
• MDR Text Key: 108996316
• Report Number: 9611253-2018-00024
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• PMA/PMN Number: K972569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

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: Dentist
• Device Model Number: FORZA F5
• Device Catalogue Number: 5021285U0
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 06/02/2018
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR