MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MAXIMA ELITE 1:5; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 6361849

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

This report summarizes 2 malfunction events where a maxima elite 1:5 handpiece overheated.In both events, a patient experienced a minor burn that did not require intervention.

Manufacturer Narrative

2 of 2 devices were returned for evaluation.Evaluation of 2 devices found excessive wear due to a lack of proper maintenance.The devices had debris build-up.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona.

• Brand Name: MAXIMA ELITE 1:5
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 15122897
• MDR Text Key: 304707404
• Report Number: 9614977-2022-00037
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6361849
• Patient Sequence Number: 1