MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST STYLUS ATC HANDPIECE; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 882300

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

1 of 1 device was returned for evaluation.Evaluation of the one returned device found excessive wear due to a lack of proper maintenance.This device did heat up during evaluation.The device was repaired and returned to the customer.

Event Description

This report summarizes 1 malfunction events.This report summarizes one malfunction event where a midwest stylus atc mini handpiece overheated during use; no injury resulted.

• Brand Name: MIDWEST STYLUS ATC HANDPIECE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 9639598
• MDR Text Key: 184714099
• Report Number: 9614977-2019-00165
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K003518
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 882300
• Type of Device Usage: N
• Patient Sequence Number: 1