MAUDE Adverse Event Report: DENTSPLY INTERNATIONAL INC. MIDWEST TRADITION; HANDPIECE, AIR-POWERED, DENTAL

Model Number 780045

Device Problem Smoking (1585)

Patient Problem No Information (3190)

Event Date 10/20/2015

Event Type  malfunction  

Event Description

Dentist was using midwest dental drill handpiece attached to peds dental console.After period of prolonged and heavy use the dentist noted smoke emanating from the connection between the handpiece and the tubing.A new hand piece was connected without the same problem.

• Brand Name: MIDWEST TRADITION
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): DENTSPLY INTERNATIONAL INC.; 221 west philadelphia st.; suite 60; york PA 17404
• MDR Report Key: 5322250
• MDR Text Key: 34208307
• Report Number: 5322250
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2015

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: Physician
• Device Model Number: 780045
• Device Catalogue Number: 780045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 YR