MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES G310SCLR(DNA); SCALER, ULTRASONIC

Catalog Number	G310SCLR
Medical Device Problem Code	Restricted Flow rate (1248)
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 300 series g310, they allege that they had slow water flow and the handpiece got hot, no injury resulted.
Additional Manufacturer Narrative
Within warranty? no.Notes: may 13, 2025.Unit serial number-(b)(6).Foot pedal serial number-(b)(6).Sterimate/handpiece lot number-(old-202110) (new-202412).Handpiece cable lot number-(old-11210) (new-02250).Repair tech: gpb.Qa: rb.Root cause: won hose,tubing, kink/pinch/twist.Water supply line was pinched between the mounting plate restricting water flow.Debris buildup in the water solenoid/would not hold water pressure.Power cord had corrosion on the prongs of the power cord.Handpiece cable was damaged with a torn black contact tip.Water leaking from 360 sterimate/handpiece.Debris buildup in the water filter.Note replaced damaged/worn components and recalibrated unit to factory specs.Within warranty? no.Dhr review is not required because the product was returned for evaluation and the described failure mode is a known hazard.

• Brand Name: CAVITRON 300 SERIES G310SCLR(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: 21875775
• Report Number: 2424472-2025-00049
• Device Sequence Number: 7653723
• Product Code: ELC
• UDI-Device Identifier: D00382703121
• UDI-Public: D00382703121
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150535
• 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: G310SCLR
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• 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