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

Catalog Number	875305
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).7 of 7 devices were returned for evaluation.Evaluation of six devices found them all to be within specification.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.
Event or Problem Description
This report summarizes 7 malfunction events where a midwest energo s 1:5 handpiece overheated.7 events resulted in no injury.

• Brand Name: MIDWEST ENERGO S 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: 21232213
• Report Number: 9614977-2024-00038
• Device Sequence Number: 21013112
• Product Code: EFB
• UDI-Device Identifier: E27668146800
• UDI-Public: E27668146800
• Combination Product (Y/N): N
• PMA/510(K) Number: K972436
• Number of Events Summarized: 7
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2025
• Patient Sequence Number: 1
• Patient Sex: Unknown