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

Catalog Number	G310SCLR
Medical Device Problem Codes	Overheating of Device (1437); No Flow (2991)
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 has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
While the customer was using a cavitron 300 series g310 they allege that the handpiece and the inserts are getting hot.No injury was reported from the alleged event.
Additional Manufacturer Narrative
Unit serial number- (b)(6).Foot pedal serial number- (b)(6).Handpiece/sterimate lot number-current-(202303).Handpiece cable lot number-current- (09230).Repair tech: (b)(4).Qa: (b)(4).Root cause: w4e water sol, iso valve clogged.No water flow due to a clogged water solenoid.Low vibration due to malfunction with the main oscillator board.Screen was cracked on the lower bottom right corner.Handpiece cable harness that has a water supply line that links to the handpiece cable harness it is damaged.By deterioration of the water supply line and heavy debris build up causing poor water flow.Debris buildup in the water supply hose and leaking near the black sleeve tubes that keep the water supply hose together.Note: replaced damaged/worn components and recalibrated unit to factory specs.

• 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: 19324055
• Report Number: 2424472-2024-00043
• Device Sequence Number: 12385388
• Product Code: ELC
• UDI-Device Identifier: D00382703111
• UDI-Public: D00382703111
• 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): 06/20/2024

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: 05/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/20/2024
• 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