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

Catalog Number	8161426
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
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 touch package-2015 it is alleged that the insert tip are overheating even with reportedly good water flow.No injury occurred.
Additional Manufacturer Narrative
Failure mode: overheating insert root cause: defective component/part defective component/part: low vibration due to malfunction with the main oscillator board.Poor communication with the wireless foot pedal, damaged handpiece cable restricting water flow when hp cable is held a certain position.Debris buildup in the water solenoid.Worn steri-mate, debris buildup in the water supply hose, debris buildup in the water filter.Conclusion code: service life or shell life exceeded customer complaints are monitored during monthly psc meetings.The failure mode mentioned in this complaint is also identified as a potential hazard in the corresponding risk management file.Therefore, no additional action is necessary.

• Brand Name: CAVITRON TOUCH 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19601081
• Report Number: 2424472-2024-00380
• Device Sequence Number: 8486387
• Product Code: ELC
• UDI-Device Identifier: D00381614261
• UDI-Public: D00381614261
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150535
• 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): 09/11/2024

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 Catalogue Number: 8161426
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown