MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON TOUCH,240V-UK,G1000; SCALER, ULTRASONIC

Catalog Number	8250003
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 cavitron touch, 240v-uk, g1000 had the insert tips get hot during use.No injury.
Additional Manufacturer Narrative
Engineer's findings: 'unit set up and evaluated, upon inspection due to the poor level of packaging inside the shipping container the lcd screen was found to be cracked from side to side and so a new screen was required to meet repair criteria.Screw housing on the inner base that holds the power supply/pcb board mounting plate had split, a new inner base was fitted to resolve this.The necessary 22psi pressure inside the handpiece could not be attained, this was due to a faulty water regulator which has been replaced.Water tubing on the bulkhead wire harness was found to be very discoloured; a new wire harness was fitted to meet repair specification.Handpiece lead was blocked and this was the primary cause of the reported fault, high pressure air was blown through the lead but this did not resolve the issue, a new handpiece lead was supplied and tested to meet repair requirement.Footswitch fully charged and powered off for transit.Repair, calibration and functionality checks carried out, unit running ok.'.

• Brand Name: CAVITRON TOUCH,240V-UK,G1000
• 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: 23758290
• Report Number: 2424472-2025-00268
• Device Sequence Number: 9934075
• Product Code: ELC
• UDI-Device Identifier: D00382500011
• UDI-Public: D00382500011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150535
• 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): 02/17/2026

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: 8250003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown