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

Catalog Number 875205

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).50 of 50 devices were returned for evaluation.Evaluation of three devices found them to be within specification.Evaluation of two devices found expected wear of the device.These devices did not overheat during evaluation.The devices were repaired and returned to the customers.Evaluation of eight 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 two devices found excessive wear due to a lack of proper maintenance.These devices did overheat during evaluation.The devices were repaired and returned to the customers.Evaluation of ten 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 one device found excessive wear due to a lack of proper maintenance.There was also evidence of friction in this device.This device did overheat during evaluation.The device was repaired and returned to the customer.Evaluation of 12 devices found excessive wear due to a lack of proper maintenance.There was also evidence of friction and debris build-up in these devices.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 evidence of friction and debris build-up in these devices.These devices did overheat during evaluation.The devices were repaired and returned to the customers.Evaluation of one device found excessive wear due to a lack of proper maintenance.There was also evidence of friction and debris build-up in this device.The device is also damaged / deformed.The device did not overheat during evaluation.The device was repaired and returned to the customer.Evaluation of one device found excessive wear due to a lack of proper maintenance.There was also debris build-up in this device.This device did overheat during evaluation.The device was repaired and returned to the customer.Evaluation of six 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.Evaluation of two devices found excessive wear due to a lack of proper maintenance.There was also evidence of friction and debris build up in these devices.There was also a lack of lubrication in these devices.These devices did not overheat during evaluation.The devices were repaired and returned to the customers.

Event Description

This report summarizes 50 malfunction events.This report summarizes 50 malfunction events where a midwest e plus 1:5 handpiece overheated.In six events, patients were burned, however no medical attention was required to treat the minor burns.In 43 of the events, there were no injuries to the patients.In one event, the patient outcome is unknown despite multiple follow-ups.

• Brand Name: MIDWEST E PLUS 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: 9257454
• MDR Text Key: 184696264
• Report Number: 9614977-2019-00127
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 50
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 875205
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Type of Device Usage: N
• Patient Sequence Number: 1