MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL TRADITION L FIBER OPTIC HS HANDPIECE; AIR-POWERED DENTAL HANDPIECE

Catalog Number 780045

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

In this event it was reported that the cap unscrewed from a tradition l handpiece while in use and the turbine fell out and became lodged in a pt's throat.The pt was taken to the er and the doctors were unable to retrieve the turbine, so they brought in a head and neck surgeon to surgically remove the turbine.

Manufacturer Narrative

Because this malfunction required surgical intervention to preclude permanent impairment/damage of a body function/structure, this event meets the definition of a reportable event per 21 cfr part 803.The device is available for eval, though results are not available as of this report.Eval results will be submitted as they become available.

• Brand Name: TRADITION L FIBER OPTIC HS HANDPIECE
• Type of Device: AIR-POWERED DENTAL HANDPIECE
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; des plaines IL
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4214916
• MDR Text Key: 16180755
• Report Number: 1419322-2014-00060
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/08/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 780045
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention