MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON JET PLUS TAP-ON(DNA) G137; SCALER, ULTRASONIC

Catalog Number G137

Device Problems Restricted Flow rate (1248); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

While using a cavitron jet plus g137, they allege that the inserts are getting hot with potential water flow issue, no injury resulted.

Manufacturer Narrative

Evaluation tech: gpb unit serial number-((b)(6)) foot pedal serial number-((b)(6)) jet-mate/handpiece/sterimate lot number-#1-(2023080)-#2-(07130) handpiece cable lot number-(09200) root cause: w4o water sol,iso valve leaking continuous water leaking due to debris buildup in the water system not allowing the solenoid to close completely damaged water flow control on the handpiece cable (water flow turn knob is loose and debris build up is restricting water flow causing the tips to get hot/warm) air manifold not exhausting properly, also the air manifold has bad regulation resulting in inconsistent powder flow, leaking air from manifold two clogged duckbill filter causing poor air/powder flow flattened pinch tube restricting air/powder flow powder bowl needs to be cleaned and retubed foot control pad is worn and needs to be replaced water supply hose missing black sleeves to secure tubing to filter luers note: will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.For proper evaluation and testing please always send in all parts that go along with the unit to be looked at.Loaner fee included on estimate additional notes: not enough water was getting to the jet-mate from the debris building up in the handpiece cable and the water solenoid and furthermore the jet-mate was leaking which was making poor water flow connection to the insert that was making the jet-mate and insert heat up with not enough water to the insert and the jet-mate.Jet air polishing insert that was sent in by customer has been evaluated and tested.The jet air polishing insert is bent and causing poor air/water flow through the jet air polishing insert.This insert is not in working manufactured standards.Jet-mate lot code-2023080-good to use it is up to manufactured specs jet-mate lot code-07130-good to use it is up to manufactured specs items not received for testing and evaluation no auxiliary foot pedal charging cord.

• Brand Name: CAVITRON JET PLUS TAP-ON(DNA) G137
• Type of Device: 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: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18707451
• MDR Text Key: 336413023
• Report Number: 2424472-2024-00010
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G137
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1