MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH T1 LINE DENTAL HANDPIECE; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 6361849

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

One device will not be returned for evaluation.This event is being submitted as part of vmsr.Only one event was received for this device during this quarter.

Event Description

This report summarizes 1 malfunction events where a t1 line handpiece overheated.No injury resulted.

• Brand Name: T1 LINE DENTAL HANDPIECE
• 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: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 19164242
• MDR Text Key: 341131474
• Report Number: 9614977-2024-00008
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2024

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: 6361849
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2024
• Patient Sequence Number: 1