MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON SELECT SPS G124 GENERATOR(DNA); SCALER, ULTRASONIC

Catalog Number	81324
Medical Device Problem Codes	Restricted Flow rate (1248); 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
While using a cavitron select sps g124 they allege that they have low water flow and the handpiece is heating up; no injury resulted.
Additional Manufacturer Narrative
May 6, 2025: unit serial number: (b)(6), sterimate/handpiece lot number: (n/a), handpiece cable lot number: (02230), evaluation tech: gpb, root cause: w4e water sol, i so valve clogged, no water flow due to a clogged water solenoid, hardened and deteriorated water supply hose with debris build in the water filter causing poor water flow, sterimate/handpiece (precautionary measure), note: will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.Loaner fee included on the estimate.Additional notes: put a sterimate/handpiece on the estimate for precautionary measure.Customer did not send in sterimate/handpiece to be evaluated and tested.Please check the sterimate/handpiece to see if the contacts pins are corroded or damaged or any cracks along the sterimate/handpiece.For proper evaluation and testing please always send in all parts that go along with the unit to be looked at.Items not received for testing and evaluation.No sterimate/handpiece.Dhr review is not required because the product was returned for evaluation and the described failure mode is a known hazard.

• Brand Name: CAVITRON SELECT SPS G124 GENERATOR(DNA)
• 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 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 21875777
• Report Number: 2424472-2025-00046
• Device Sequence Number: 20746604
• Product Code: ELC
• UDI-Device Identifier: D00381614241
• UDI-Public: D00381614241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 81324
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown