MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST TRADITION PB FIBER OPTIC; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 790045

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

There have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Dentsply was not able to verify the complaint.The returned handpiece was tested by manufacturing personnel and met all specification criteria.The handpiece exhibited maximum temperature of 22.8°c during free run testing.Per iso 13732-1, this temperature level does not qualify as a burn regardless of the contact period.The handpiece was not cutting as received.The handpiece was then microscopically evaluated.All set components looked good.Cap cavity also looked good.Head cavity appeared to be a little dry.

Event Description

In this event a doctor reported that a tradition handpiece overheated and burned a patient on the inside of their cheek.It is unknown if intervention was required.Additional information has been requested, but is not yet available.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: MIDWEST TRADITION PB FIBER OPTIC
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 901 west oakton st.; des plaines IL 60018
• Manufacturer (Section G): DENTSPLY PROFESSIONAL; 901 west oakton st.; des plaines IL 60018
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6164971
• MDR Text Key: 62205963
• Report Number: 1419322-2016-00310
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 790045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• 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