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

Catalog Number 3328452

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

2 of 2 devices were returned for evaluation.Evaluation of one device found excessive wear due to a lack of proper maintenance.There was also debris build up in this device.This devices did overheat during evaluation.The device was repaired and returned to the customer.Evaluation of one device found excessive wear due to a lack of proper maintenance.This devices did overheat during evaluation.The device was repaired and returned to the customer.

Event Description

This report summarizes 2 malfunction events.This report summarizes two malfunction events where a t1 line handpiece overheated.There was no injury to any patients.

• Brand Name: T1 LINE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 9257458
• MDR Text Key: 184715867
• Report Number: 9614977-2019-00129
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3328452
• Type of Device Usage: N
• Patient Sequence Number: 1