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

Catalog Number G137

Device Problem Restricted Flow rate (1248)

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

Event Type  malfunction  

Event Description

While using a cavitron jet plus g137 they allege that low water flow to handpiece and handpiece is getting hot; no injury resulted.

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.

Manufacturer Narrative

05/29/24 evaluation tech: mjo.Xjv ft control, cable, recep open.Inconsistent activation of wireless foot pedal in second position.Moisture found in powder bowl and air manifold.Clogged duckbill filter causing poor air/powder flow, no batteries in foot pedal.Worn jet-mate nozzle grip.Cracked aux port on bracket board.Could not duplicate customer's complaint.Water flow present.Advise customer to ensure water pressure to unit is at recommended 40psi.Will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.Hpc - 05220.Hp - 04150.

• 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: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 19149596
• MDR Text Key: 341137510
• Report Number: 2424472-2024-00031
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D00381614281
• UDI-Public: D00381614281
• 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: 05/30/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: G137
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• 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