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

Catalog Number	G139
Medical Device Problem Codes	Restricted Flow rate (1248); 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 cavitron integrated system built in ultrasonic scaler g139 they allege that the insert gets really hot with little water.No injury was reported from the alleged event.
Additional Manufacturer Narrative
G139-27042 rev11.Emh hp;cable,conn/gun cable damaged.Hp cable and 360 hp received for evaluation.Unit works fine but the hp cable has exposed wires and the water regulator is partially clogged causing poor water flow, 360 hp has a bent pin.Replaced the listed parts, checked for performance, cleaned and final test.

• Brand Name: CAVITRON INTEGRATED SYSTEM BUILT IN ULTRASONIC 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: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18317728
• Report Number: 2424472-2023-00060
• Device Sequence Number: 17670965
• Product Code: ELC
• UDI-Device Identifier: D00388001041
• UDI-Public: D00388001041
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 01/04/2024

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): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/04/2024
• 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