MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES G310SCLR(DNA); 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
Event or Problem Description
While using a cavitron 300 series g310, they allege that they have low water flow and a hot handpiece, no injury resulted.
Additional Manufacturer Narrative
(b)(6) 2024 repair tech: (b)(4).E1h probe,inner module,hp damaged.Insert was stuck in the sterimate, back of sterimate was separated.Touchscreen lag.Debris buildup in the handpiece cable.Debris buildup in the water filter.Replaced damaged/worn components and recalibrated unit to factory specs.No power cord received for evaluation." qa -ds.Handpiece # : old 202308 -- new 202408.Handpiece cable # : old 07200 -- new 07240.

• 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: 20383069
• Report Number: 2424472-2024-00089
• Device Sequence Number: 12403514
• 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): 11/15/2024

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: 10/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/15/2024
• 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