MAUDE Adverse Event Report: NSK NAKANISHI INC FORZA M5 1:5 ATTACHMENT SHORTY FG HIGH SPEED OPTIC; HANDPIECE

Model Number 5021285U0

Device Problems Break (1069); Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/09/2021

Event Type  malfunction  

Event Description

Customer reports two broken, overheating and bad sounding handpieces.A patient's lower right lip and lip inside cheek was burned (b)(6), male) during a crown prep.Topical [benzocaine] was applied and triple antibiotic ointment and 800mg ibuprofen was advised.The doctor does not think there will be scarring.In the same report, the customer said another patient's lip was burned a few weeks prior (no pt information was provided).The doctor says he can't always know when they are overheating and if the patient's lip is numb, they can't feel it either.Plenty of water is run through the handpieces, fresh burs are used and the handpieces are run through an oil machine between each use.

Event Description

Customer reports two broken, overheating and bad sounding handpieces.A patient's lower right lip and lip inside cheek was burned (initials he, age 18, male) during a crown prep.Topical [benzocaine] was applied and triple antibiotic ointment and 800mg ibuprofen was advised.The doctor does not think there will be scarring.In the same report, the customer said another patient's lip was burned a few weeks prior (no pt information was provided).The doctor says he can't always know when they are overheating and if the patient's lip is numb, they can't feel it either.Plenty of water is run through the handpieces, fresh burs are used and the handpieces are run through an oil machine between each use.

• Brand Name: FORZA M5 1:5 ATTACHMENT SHORTY FG HIGH SPEED OPTIC
• Type of Device: HANDPIECE
• Manufacturer (Section D): NSK NAKANISHI INC; 700 shimohinata kanuma tochigi; 322-8666; JA
• MDR Report Key: 11576576
• MDR Text Key: 243902461
• Report Number: 1032227-2021-00003
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/25/2021,03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5021285U0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2021
• Distributor Facility Aware Date: 03/12/2021
• Event Location: Other
• Date Report to Manufacturer: 03/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR