MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E MICRO ELECTRIC MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number 875045

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 device found lack of proper maintenance and excessive wear.The device was cleaned, repaired and returned to the customer.

Event Description

This report summarizes 1 malfunction events.This report summarizes one malfunction event where a midwest e micro electric motor caused a handpiece to overheat.There was no injury in this event.

• Brand Name: MIDWEST E MICRO ELECTRIC MOTOR
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer (Section G): SYCOTEC GMBH & CO KG; wangener strasse 78; leutkirch baden-wurttemberg, 88299 ; GM 88299
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 8847864
• MDR Text Key: 184718126
• Report Number: 9614977-2019-00117
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• PMA/PMN Number: K090937
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 875045
• Type of Device Usage: N
• Patient Sequence Number: 1