MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MAXIMA ELITE BY HENRY SCHEIN; MAXIMA ELITE BY HENRY SCHEIN / HANDPIECE

Model Number 1:5

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 02/14/2019

Event Type  Injury  

Event Description

While the dentist was conducting tooth fillings and crown preparations, a handpiece started heating up and burned two patients' cheek as soon as friction was applied to the tooth.One of the patient was prescribed with pain medication and required a follow-up with the dentist.This issue occurred with the use of three (3) handpieces.Both patients received a burn which was localized inside of the cheek where the handpiece made contact with oral tissue.The customer returned all three (3) handpieces associated with this event.However, he did not specify which of the handpiece(s) caused the localized burns.Therefore, we've list all three (3) serial numbers in question.According to the customer, the handpieces sent back caused a lot of heat when the head chuck has pressure placed on it.This was observed by the dentist through applying pressure on the head chuck as well as in the patients' mouth while working on the teeth on the buccal side against the cheek.In other words, the dentist indicated that the handpieces were pressed against the patients' cheeks during dental operations, which attributed to the localized burns.The ifu (instruction for use), included with this product, has two cautionary statements regarding the risk of burning patient's cheek; therefore, this event may be attributed to user error.

• Brand Name: MAXIMA ELITE BY HENRY SCHEIN
• Type of Device: MAXIMA ELITE BY HENRY SCHEIN / HANDPIECE
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim D-646 25; GM D-64625
• MDR Report Key: 8436912
• MDR Text Key: 139339661
• Report Number: 3007007357-2019-00001
• Device Sequence Number: 1
• Product Code: EFA
• 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: 03/20/2019,02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1:5
• Device Catalogue Number: 112-5681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2019
• Distributor Facility Aware Date: 02/19/2019
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2019
• 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: 29 YR