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

Catalog Number	875305
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional serial numbers included in this report: (b)(6).6 of 6 devices were returned for evaluation.Evaluation of one device found it to be within specification.Evaluation of one device found excessive wear due to a lack of proper maintenance.The device did not heat up 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.This device had a deformation issue (dent).The device did not heat up during evaluation.The device was repaired and returned to the customer.Evaluation of two devices found excessive wear due to a lack of proper maintenance.This devices had a deformation issue (dent).A friction problem was identified from pressure on the cap.The devices did not heat up 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.A friction problem was identified from pressure on the cap.The device did not heat up during evaluation.The device was repaired and returned to the customer.
Event or Problem Description
This report summarizes 6 malfunction events where midwest energo 1:5 handpieces overheated.4 events resulted in no injury.2 events resulted in unknown injury.
Additional Manufacturer Narrative
This follow up report provides the requested update to add vmsr to the exemption/variance number field.

• Brand Name: MIDWEST ENERGO 1:5
• Common Device Name: 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: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 23389477
• Report Number: 9614977-2025-00038
• Device Sequence Number: 10034314
• Product Code: EFB
• UDI-Device Identifier: E27668146800
• UDI-Public: E27668146800
• Combination Product (Y/N): N
• PMA/510(K) Number: K972436
• Exemption Number: VMSR
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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 Catalogue Number: 875305
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 02/02/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown