MAUDE Adverse Event Report: DENTSPLY LLC CAV.PLUS TAP-ON,240V-UK-G136; SCALER, ULTRASONIC

Catalog Number	8184003
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
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.
Event or Problem Description
In this event it is reported that while using a cav.Plus tap-on, 240v-uk-g136, it is alleged that the sterimate gets hot.Inserts and water flow to be checked.No injury.
Additional Manufacturer Narrative
Investigation results.Failure mode - overheating handpiece.Root cause - user technique problem.Conclusion code - user error.A dhr review is unnecessary for this complaint, as the reported issue was successfully resolved once the user followed the required instructions.

• Brand Name: CAV.PLUS TAP-ON,240V-UK-G136
• 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: 22099928
• Report Number: 2424472-2025-00229
• Device Sequence Number: 7343260
• Product Code: ELC
• UDI-Device Identifier: D00381840021
• UDI-Public: D00381840021
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 8184003
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/19/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown