MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES PACKAGE; SCALER, ULTRASONIC

Catalog Number	8161429
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that cavitron 300 series package, it is alleged that the unit always seems to heat up , with tip and sterimate getting hot.No injury occurred.
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.
Additional Manufacturer Narrative
Investigation: dhr review is not required because the product was returned for evaluation and the customer complaint is a known hazard.Based on the repair notes, the service technician was unable to duplicate the failure as stated in the complaint.Recommended repairs were made as part of preventive maintenance for continued system operation.Failure mode - overheating insert.Root cause - damaged contact pin on the steri-mate handpiece.Debris buildup in the water filter.Conclusion code - expected wear.

• Brand Name: CAVITRON 300 SERIES PACKAGE
• 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: 20293707
• Report Number: 2424472-2024-00394
• Device Sequence Number: 8127487
• Product Code: ELC
• UDI-Device Identifier: D00381614291
• UDI-Public: D00381614291
• 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): 12/17/2024

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: 8161429
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown