MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E PRO 1:5; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 875105

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).12 of 12 devices were returned for evaluation.Evaluation of two devices found excessive wear due to a lack of proper maintenance.These devices did not overheat during evaluation.The devices were repaired and returned to the customers.Evaluation of five devices found excessive wear due to a lack of proper maintenance.There was also evidence of friction in these devices.These devices did not overheat during evaluation.The devices were repaired and returned to the customers.Evaluation of three devices found excessive wear due to a lack of proper maintenance.There was also evidence of friction in these devices and debris build up.These devices did not overheat during evaluation.The devices were repaired and returned to the customers.Evaluation of two devices found excessive wear due to a lack of proper maintenance.There was also debris build-up in these devices.These devices did not overheat during evaluation.The devices were repaired and returned to the customers.

Event Description

This report summarizes 12 malfunction events.This report summarizes 12 malfunction events where a midwest e pro 1:5 handpiece overheated.In one event, a patient was burned, however no medical attention was required to treat the minor burn.In 11 of the events, there were no injuries to the patients.

• Brand Name: MIDWEST E PRO 1:5
• 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: 9257455
• MDR Text Key: 184698521
• Report Number: 9614977-2019-00126
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 12
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 875105
• Type of Device Usage: N
• Patient Sequence Number: 1