MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MAXIMA ELITE ELECTRIC CA; HANDPIECE

Model Number MAXIMA ELITE ELECTRIC CA

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 02/21/2024

Event Type  Injury  

Event Description

Dentist has stated that the handpiece "runs hot" and is "burning patients".Upon evaluation the handpiece supervisor has stated the following: normal wear and tear internally for 10 months into a 1-year repair.Passes out current draw test and does not overheat with normal use.The only issue i have found is the user pressing the push button most likely patient's cheek/mouth causing the chuck to rub on the button and heat up.

Event Description

Dentist has stated that the handpiece "runs hot" and is "burning patients".Upon evaluation the handpiece supervisor has stated the following: normal wear and tear internally for 10 months into a 1-year repair.Passes out current draw test and does not overheat with normal use.The only issue i have found is the user pressing the push button most likely patient's cheek/mouth causing the chuck to rub on the button and heat up.

• Brand Name: MAXIMA ELITE ELECTRIC CA
• Type of Device: HANDPIECE
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; benscheim d-64625 ; GM
• MDR Report Key: 18903781
• MDR Text Key: 337659690
• Report Number: 3007007357-2024-00008
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: MAXIMA ELITE ELECTRIC CA
• Device Catalogue Number: 112-5681
• Device Lot Number: 2107111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2024
• Distributor Facility Aware Date: 02/16/2024
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/14/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other