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); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This report summarizes 42 malfunction events where a midwest e plus handpiece overheated.In 6 events, the patient outcome is unknown despite reasonable follow-ups.In 8 events, a patient experienced a minor burn that did not require intervention.In 28 events, no injury resulted.

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).41 of 42 devices were returned for evaluation.1 device will not be returned for evaluation.Evaluation of 3 devices found them all to be within specification.Evaluation of 4 devices found excessive wear due to a lack of proper maintenance and lubrication.The devices had debris build-up.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.Evaluation of 1 device found excessive wear due to a lack of proper maintenance and lubrication.The device had debris build-up.The device did heat up during evaluation.The device was repaired and returned to the customer.Evaluation of 29 devices found excessive wear due to a lack of proper maintenance.The devices had debris build-up.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.Evaluation of 4 devices found excessive wear due to a lack of proper maintenance.The devices had debris build-up.The devices did heat up during evaluation.The devices were repaired and returned to the customers.

• Brand Name: MIDWEST E PLUS 1:5
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 15122915
• MDR Text Key: 298575563
• Report Number: 9614977-2022-00036
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 42
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 875205
• Patient Sequence Number: 1