MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON SELECT RESERVOIR(DNA) G123; SCALER, ULTRASONIC

Catalog Number	G123
Medical Device Problem Code	No Flow (2991)
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.Investigation results: "04/21/2025: evaluation tech: (b)(6).Er3 motor, pump worn.G123 - poor air pressure regulation, low water flow due to debris buildup in isolation valve, debris buildup in the water filter.Cracked l connector.G124 - no issues found.Unit is functioning properly.Recommend checking all inserts being used are not worn, corroded, damaged and /or clogged.Will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.Handpiece#: 202405.Handpiece cable#: 04240.
Event or Problem Description
While using a cavitron select sps w/reservoir g123, they allege that no water is going through and the handpiece gets hot, no injury resulted.

• Brand Name: CAVITRON SELECT RESERVOIR(DNA) G123
• 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: 21875778
• Report Number: 2424472-2025-00047
• Device Sequence Number: 15367043
• Product Code: ELC
• UDI-Device Identifier: D003901461
• UDI-Public: D003901461
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970123
• 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): 04/21/2025

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: G123
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/21/2025
• 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