MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON JET PLUS W/TAPON-115V G137(DNA); SCALER, ULTRASONIC

Catalog Number	8187501
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
Additional Manufacturer Narrative
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 the customer was using a cavitron jet plus g137, they allege that the handpiece and insert are heating up during use.No injury was reported from the alleged event.
Additional Manufacturer Narrative
Hpc# (b)(4).Sterimate# (b)(4).W2e reg, needle valve, hp flow cntrl clogged.Poor/no water flow due to a partially clogged hp cable.Poor water pressure/flow due to debris buildup in water solenoid.Clogged duckbill filters causing poor air/powder flow.Flattened and pinched tubing.Powder bowl cracked.Peeling foot pedal pad.Worn battery door water supply hose quick disconnect leaking water/corroded.Will replace damaged /worn components and recalibrate unit to factory specs upon estimate approval.Dhr review is not required because the product is outside of useful life and the customer issue is a known hazard.

• Brand Name: CAVITRON JET PLUS W/TAPON-115V G137(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: 21210017
• Report Number: 2424472-2025-00007
• Device Sequence Number: 8070406
• Product Code: ELC
• UDI-Device Identifier: D00381875011
• UDI-Public: D00381875011
• Combination Product (Y/N): N
• 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): 04/07/2025

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: 8187501
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 04/07/2025
• 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