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

Catalog Number	8184003
Medical Device Problem Code	No Flow (2991)
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 a cav.Plus tap-on,240v-uk-g136 allegedly has no water flow.No injury occurred.
Additional Manufacturer Narrative
Unit set up and evaluated, upon inspection the reported fault of no water flow could not be replicated however water flow did struggle to meet the required 55cc/min, high pressure air was blown through the lead and that has resolved this issue.Handpiece lead and sterimate was tested for continuity with no issues found.O ring inside the handpiece lead socket was slightly worn, a new o ring was fitted to ensure a good seal between the handpiece lead socket and handpiece.Mains lead plug would not heal correctly into the scaler's entry socket; a new mains lead was supplied to meet repair specification.Repair, calibration and functionality checks carried out, unit running ok dhr review is not required because the product was returned for evaluation, and the described failure mode is a known hazard.

• 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: 24292717
• Report Number: 2424472-2026-00514
• Device Sequence Number: 10381772
• 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): 05/05/2026

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: 02/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown