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

Catalog Number	875315
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
3 of 3 devices were returned for evaluation.Evaluation of three devices found excessive wear due to a lack of proper maintenance.The three devices were getting warmer than expected.Over lubrication was found and this can lead to an increase in temperature.The devices did heat up during evaluation.The devices were repaired and returned to the customers.
Event or Problem Description
This report summarizes 3 malfunction events where a midwest energo 1:5 handpiece overheated.3 events resulted in no injury.

• 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: 19805658
• Report Number: 9614977-2024-00017
• Device Sequence Number: 12700080
• Product Code: EFB
• UDI-Device Identifier: E27668146800
• UDI-Public: E27668146800
• Combination Product (Y/N): N
• PMA/510(K) Number: K972436
• Number of Events Summarized: 3
• 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): 07/22/2024

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: 875315
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown