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

Catalog Number	G310SCLR
Medical Device Problem Codes	Restricted Flow rate (1248); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
While using a cavitron 300 series g310 they allege that they have low water flow and the handpiece heats up; no injury resulted.
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.This complaint was initially entered as a unit heating up with low water flow but it was revealed during the evaluation that the handpiece was also heating up, making it a reportable case.Even though the aware date is 01/03/2024, the case was deemed reportable after product evaluation on 3/12/2024 which becomes the new aware date for reportability.Investigation findings notes: march 12, 2024 repair tech: gpb qa: mo foot pedal serial number-current-(b)(6) handpiece/sterimate lot number-current-2022053 handpiece cable lot number-current-05220 root cause: w4h water sol,iso valve damaged ********************************************* debris buildup in the water solenoid causing poor water flow and the water solenoid was also not holding manufactured standard pressure heavy debris buildup in the water filter ********************************************* note: replaced damaged/worn components and recalibrated unit to factory specs.********************************************* additional notes: water solenoid had debris build up and heavy debris build up in the water filter which was leading to low water flow during testing the unit.This would be the reason why the handpiece/sterimate was heating up.

• 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: 18887182
• Report Number: 2424472-2024-00019
• Device Sequence Number: 7774086
• 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
• Report Date (Section B): 03/12/2024

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: 03/12/2024
• Initial Report FDA Received Date: 03/12/2024
• 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