MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON PLUS TAP-ON(DNA) G136; SCALER, ULTRASONIC

Catalog Number	G136
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.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 plus g136, they allege that they have low water flow and the handpiece overheats, no injury resulted.
Additional Manufacturer Narrative
Notes: 07/03/25, evaluation tech: (b)(4).W4d water sol, iso valve build up/debris continuous water leaking due to debris buildup in the water system not allowing the solenoid to close completely.Water supply hose quick disconnect corroded.Debris buildup in the water filter.Low vibration due to malfunction with the main oscillator board.Dead batteries in wireless foot pedal.Worn and peeling foot control pad.Intermittent or no operation due to an open condition in the handpiece cable/corroded contact pins.Will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.Hand piece is getting warm due to corroded contact pins on the handpiece cable not allowing enough water to reach the handpiece.Hp 09/2019, hdpc 06/2019.

• Brand Name: CAVITRON PLUS TAP-ON(DNA) G136
• 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: 22235678
• Report Number: 2424472-2025-00081
• Device Sequence Number: 9042075
• Product Code: ELC
• UDI-Device Identifier: D00381840021
• UDI-Public: D00381840021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052334
• 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): 08/28/2025

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: G136
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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