MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON JET PLUS PACKAGE-2015; SCALER, ULTRASONIC

Catalog Number	8161428
Medical Device Problem Code	Overheating of Device (1437)
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
In this event it is reported that cavitron jet plus package-2015 allegedly is heating up due to lack of water flow.No injury occurred.
Additional Manufacturer Narrative
Adding udi # - udi # (b)(4).This is a follow up report to add this information.Investigation results: this unit was already received in york under rma 483746.Estimated the customer for repair and customer refused.Unit has been shipped back to the customer.Following is the inspection notes we received from york.Hose,tubing,build up/debris cracked auxiliary foot pedal connector on the power drive board.Debris buildup in the handpiece cable, low oscillation due to trouble with the jetmate handpiece.Cracked duckbill filters, flattened pinch tube restricting air/powder flow, cracked powder bowl.Debris buildup in the water filter.Cabinet has broken body posts.Will replace damaged/worn components and recalibrated unit to factory specs upon estimate approval.

• Brand Name: CAVITRON JET PLUS PACKAGE-2015
• 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16973595
• Report Number: 2424472-2023-00376
• Device Sequence Number: 15077942
• Product Code: ELC
• UDI-Device Identifier: D00381614281
• UDI-Public: D00381614281
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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 Catalogue Number: 8161428
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown