MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON INTEGRATED SYSTEM BUILT IN ULTRA SONIC SCALER G139; SCALER, ULTRASONIC

Catalog Number	G139
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
While the customer was using a g139 they allege that the handpiece is getting hot and the inserts are melting.No injury was reported from the alleged event.
Additional Manufacturer Narrative
08/06/2024 mu, g139-34066 rev 13.000 evaluated, meets specifications; contact customer.No hp received for evaluation.Unit was received with a hp cable and a canbass wire connector, the module with the hp cable have been running for over two hours without any problem, no signs of heating, the test hp feels normal and the module runs ok.The installation needs to be checked, it looks like the module is running thru the canbass connector but we need to make sure that the drive air harness is not connected due to it may cause problems with the performance of the unit.For this type of installation (canbass)the potentiometer harness with the drive air assy does not need to be connected, the only thing required is the harness with the two blue wires for power and the canbass connector takes care of everything else.Customer needs to make sure about the right installation.Checked unit for performance, cleaned and final test.Qa/jb.

• Brand Name: CAVITRON INTEGRATED SYSTEM BUILT IN ULTRA SONIC SCALER G139
• 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: 19818865
• Report Number: 2424472-2024-00063
• Device Sequence Number: 8891758
• Product Code: ELC
• UDI-Device Identifier: D00388001041
• UDI-Public: D00388001041
• 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): 08/07/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: G139
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/07/2024
• 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