MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST STYLUS LITE 360S (EASYCARE); AIR-POWERED DENTAL HANDPIECE

Catalog Number 791500

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

In this event a doctor reported that a bur fell out of the handpiece and the patient swallowed the bur.The patient was sent to the hospital and the bur was surgically removed.

Manufacturer Narrative

Because a serious injury occurred, and intervention was required, this event meets the criteria for reportability per 21 cfr part 803.The returned handpiece was evaluated and met all specifications.There was no evidence of the bur coming out during normal testing conditions or under a 50% addition in drive air pressure from the engineering specification of 40psig.Microscopic evaluation showed some debris inside the cap and head cavities and within the set assembly.A dent was also observed on the handpiece manifold.All components looked dry and no presence of lubricant was evident.

• Brand Name: MIDWEST STYLUS LITE 360S (EASYCARE)
• Type of Device: AIR-POWERED DENTAL HANDPIECE
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; des plaines IL
• Manufacturer Contact: helen lewis ; susquehanna commerce ctr w.; 221 w. philadelphia st., ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4600737
• MDR Text Key: 5468080
• Report Number: 1419322-2015-00012
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003518
• 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: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 791500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention