MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON PLUS TAP-ON(DNA) G136; SCALER, ULTRASONIC

Catalog Number	G136
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
While the customer was using a cavitron plus g136 they allege that the inserts are heating up.No injury was reported from the alleged event.
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
(b)(6) 2025.Unit serial number-((b)(6)).Foot pedal serial number-((b)(6)).Sterimate/handpiece lot number-(201410).Handpiece cable lot number-(10190).Evaluation tech: (b)(6).Root cause: emh hp; cable, conn/gun cable damaged.Handpiece cable is damaged with exposed wires and debris build up.Cabinet and top cover has broken body posts.Water leaking from sterimate/handpiece.Dead batteries in wireless foot pedal.Debris buildup in the water solenoid.Peeling wireless foot pedal pad.Worn battery door.Debris build up in the water filter.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.Items not received for testing and evaluation.No auxiliary foot pedal charging cord.Dhr review is not required because the product was returned for evaluation and the described failure mode is a known hazard.

• Brand Name: CAVITRON PLUS TAP-ON(DNA) G136
• 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 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 21298468
• Report Number: 2424472-2025-00015
• Device Sequence Number: 9199490
• Product Code: ELC
• UDI-Device Identifier: D00381614251
• UDI-Public: D00381614251
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: G136
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown