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 No Consequences Or Impact To Patient (2199); Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).45 of 46 devices were returned for evaluation.1 device will not be returned for evaluation.Evaluation of 13 returned devices found excessive wear due to a lack of proper maintenance.The devices did not heat up during evaluation.The devices were repaired and returned to the customer.Evaluation of 2 returned devices found excessive wear due to a lack of proper maintenance.The devices did heat up during evaluation.The devices were repaired and returned to the customer.Evaluation of 2 returned devices found excessive wear due to a lack of proper maintenance.There was also evidence of debris build-up.The devices did not heat up during evaluation.The devices were repaired and returned to the customer.Evaluation of 5 returned devices found excessive wear due to a lack of proper maintenance.There was also evidence of debris build-up.The devices did heat up during evaluation.The devices were repaired and returned to the customer.Evaluation of 4 returned device found excessive wear due to a lack of proper maintenance.There was also a lack of lubrication and evidence of debris build-up and friction.This devices did not heat up during evaluation.The device was repaired and returned to the customer.Evaluation of 4 returned devices found excessive wear due to a lack of proper maintenance.There was evidence of friction in these devices.The devices did not heat up during evaluation.The devices were repaired and returned to the customer.Evaluation of 13 returned devices found excessive wear due to a lack of proper maintenance.There was evidence of friction and debris build-up in these devices.The devices did not heat up during evaluation.The devices were repaired and returned to the customer.Evaluation of 2 returned devices found excessive wear due to a lack of proper maintenance.There was evidence of friction and debris build-up in these devices.The devices did heat up during evaluation.The devices were repaired and returned to the customer.

Event Description

This report summarizes 46 malfunction events.This report summarizes 46 malfunction events where a midwest e plus 1:5 handpiece overheated during use.In six events, patient's were burned, but they did not require any intervention to treat the minor burn.In 40 events, there were no injuries.

• 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: 9639628
• MDR Text Key: 184710718
• Report Number: 9614977-2019-00164
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 46
• 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

• 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: 01/28/2020
• Type of Device Usage: N
• Patient Sequence Number: 1