MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH T1 CLASSIC S 200 L; HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL

Catalog Number	5898866
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are awaiting the return of 1 device.This event is being submitted as part of vmsr.Only one event was received for this device during this quarter.
Event or Problem Description
This report summarizes 1 malfunction event where a t1 classic s 200 l handpiece overheated.The 1 event resulted in no injury.

• Brand Name: T1 CLASSIC S 200 L
• Common Device Name: HANDPIECE, BELT AND/OR GEAR DRIVEN, 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.; york, PA 17401 ; 7178494593
• MDR Report Key: 18556641
• Report Number: 9614977-2023-00050
• Device Sequence Number: 7597680
• Product Code: EFA
• UDI-Device Identifier: E27658988660
• UDI-Public: E27658988660
• Combination Product (Y/N): N
• PMA/510(K) Number: K965238
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2024

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 Catalogue Number: 5898866
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown