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

Catalog Number	875415
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional serial numbers included in this report: (b)(6).5 of 5 devices were returned for evaluation.Evaluation of one device found it to be within specification.Evaluation of four devices found excessive wear due to a lack of proper maintenance.The device did not heat up during evaluation.The devices were repaired and returned to the customers.
Event or Problem Description
This report summarizes 5 malfunction events where a midwest energo 1:5 handpiece overheated.5 events resulted in no 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: 23389460
• Report Number: 9614977-2025-00034
• Device Sequence Number: 9978955
• 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: 5
• 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: 875415
• 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