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
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 results are not available as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that a cav.Plus tap-on, 240v-uk-g136 allegedly the inserts are overheating.No injury occurred.
Additional Manufacturer Narrative
Dhr review is not required because the product was returned for evaluation.The service technician could not replicate the failure noted in the complaint with the returned unit.No additional action is necessary.Engineer's findings: 'unit set up and evaluated, upon inspection there was no issues found with the scaler as all repair, functionality and calibration checks were passed.Temperature was taken at the insert tip with the scaler running at full power and with the waterflow set at 35cc/min, temperature was measured at 30.5 degrees celsius which is well within operating parameters.Possible causes of the insert tip overheating is poor waterflow, check that the waterline filter is not clogged as this can cause significant drops in waterflow rates if the filter is not changed regularly, also if you are using a chairside portable bottle for your water supply please check that there are no leaks in the system and that the pressure inside the bottle is at least 20psi.Overheating insert tips are also a common sign that the insert tip is worn and will need replacing.Operating the insert tip at a high power level but with the water control on the handpiece lead socket set low can also lead to high levels of heat being generated as there isn't enough waterflow to keep the handpiece cool, the more power you require the more the water control needs to be turned up to keep pace with the extra power required.Handpiece lead was tested for continuity with no issues found.A new o ring was fitted as the old one was worn.Repair, calibration and functionality checks carried out, unit running ok.'.

• 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: 23051410
• Report Number: 2424472-2025-00253
• Device Sequence Number: 15962087
• 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): 12/18/2025

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: 8184003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/12/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown