MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST STYLUS ATC HANDPIECE; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 882300

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

Though no medical/surgical intervention was required to preclude a serious injury in this event, 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.First the returned handpiece was tested by manufacturing personnel.The handpiece did not heat up but it was noted by manufacturing personnel that the handpiece is assembled with non-midwest cartridge.Quality personnel then investigated the handpiece.The maximum temperature of the handpiece while free running was 22.9 c.Per iso 13732-1, this temperature level does not qualify as a burn regardless of the contact period.Poor lubrication of the head cavity most likely caused lodging of the outer race of the set inside of the cap which led to set instability.This frictional contact most likely led to the heating of the cap area and failure of all cut testing.All components looked dry with no sign of lubrication present.

Event Description

In this event a doctor reported that an atc mini handpiece overheated and burned the doctor.There was no intervention required.

• Brand Name: MIDWEST STYLUS ATC HANDPIECE
• 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: 5278873
• MDR Text Key: 33068950
• Report Number: 1419322-2015-00138
• 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: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 882300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2012
• 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