MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES G310SCLR; 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.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 have low water flow and the handpiece is getting hot, no injury resulted.
Additional Manufacturer Narrative
Sak w4h customer states hpc gets hot and it has low water flow, found unit to have sufficient water flow through test hpc/sterimate, hpc and sterimate was not with unit when received for evaluation.Also found no heating issues using known good hpc and steri-mate along with a dentsply test insert.Did find foot control has at least two "dead spots" where boost mode does not activate and water solenoid/regulator does not hold set pressure.Also found triple stacked water filters on water hose.Estimated unit for missing items, water solenoid, foot control, and water filter.Estimated unit accordingly.If customer wishes to supply missing items along with an insert that was exhibiting heating issues estimate can be revaluated.No sterimate or hpc was with unit.

• Brand Name: CAVITRON 300 SERIES G310SCLR
• 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: 18921630
• Report Number: 2424472-2024-00020
• Device Sequence Number: 15374326
• 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): 04/05/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/05/2024
• 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