MAUDE Adverse Event Report: DENTSPLY LLC 30K STERI-MATE 360 TOUCH 1PACK; SCALER, ULTRASONIC

Catalog Number	8183201
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that 30k steri-mate 360 touch 1pack is alleged to got so hot, steamng and melted to the insert.Patient was not involved but a hygienist hand was burned.The burned area was treated with polysporin.
Additional Manufacturer Narrative
There has been a previous report received where lack of water flow has caused an overheating insert.Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
During the investigation, the device had not been received, and the lot number information required for a device history record (dhr) review was not provided.

• Brand Name: 30K STERI-MATE 360 TOUCH 1PACK
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 22063876
• Report Number: 2424472-2025-00227
• Device Sequence Number: 7634448
• Product Code: ELC
• UDI-Device Identifier: D00381614261
• UDI-Public: D00381614261
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023697, K05
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 8183201
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/21/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown