MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES 310SCLR; SCALER, ULTRASONIC

Catalog Number	G310SCLR
Medical Device Problem Codes	Restricted Flow rate (1248); Overheating of Device (1437); No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
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 cavitron 300 series g310 had minimal to no water flow and was getting hot.Outcome is unknown as of this mdr.
Additional Manufacturer Narrative
Root cause: w4e water sol,iso valve clogged debris buildup in the water solenoid causing poor water flow.Handpiece cable harness that has a water supply line that links to the handpiece cable harness it is damaged by deration of the water supply line and debris build up.Damaged handpiece cable that has been cut in multiple pieces and there are exposed wires.Debris build up in the water supply hose and the quick disconnect has a broken stem fitting on the water needle valve.Note: will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.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 360 handpiece/sterimate.Dhr review is not required because the product was returned for evaluation and the customer complaint is a known hazard.Customer complaint is a known possible hazard and is tracked as part of monthly psc meetings.

• Brand Name: CAVITRON 300 SERIES 310SCLR
• 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: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18150160
• Report Number: 2424472-2023-00054
• Device Sequence Number: 5602515
• Product Code: ELC
• UDI-Device Identifier: D00382703131
• UDI-Public: D00382703131
• 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): 12/13/2023

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: 11/13/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/13/2023
• 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