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

Catalog Number	8187501
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 jet plus g137, they allege that they have low water flow and the handpiece is heating up, no injury resulted.
Additional Manufacturer Narrative
Auy plumbing/manifold oil/moisture unit has been crosslined, water in the air system, causing powder to stick together and harden in the manifold and bowl assembly, oil/water contamination in the air supply hose, clogged duckbill filter causing poor air/powder flow, clogged pinch tube causing no powder flow, powder buildup in the bowl and cap threads causing an air leak and poor powder flow.Poor water flow regulation, hardened and deteriorated water supply hose, debris buildup in the water filter.No batteries in wireless foot pedal, damaged water flow control on the handpiece cable, corroded contact pins on the jet-mate handpiece (# 08170).Will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval *loaner fee has been included in the estimate.3 x handpieces # : 2 x 09170, 1 x 08170.Handpiece cable # : 11170.

• 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: 20383068
• Report Number: 2424472-2024-00088
• Device Sequence Number: 6565826
• Product Code: ELC
• UDI-Device Identifier: D00381875011
• UDI-Public: D00381875011
• 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): 11/25/2024

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: 8187501
• 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: 11/25/2024
• 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