MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON BUILT-IN (G139) WITH 66" GRAY CABLE AND STERI-MATE HANDPIECE(DNA; SCALER, ULTRASONIC

Catalog Number	8800005
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 tip is overheating.No injury was reported from the alleged event.
Additional Manufacturer Narrative
W2e reg, needle valve, hp flow control clogged hp cable and hp received for evaluation.No fault found with the unit but the inline water regulator is partially clogged getting insufficient water flow thru the hp causing the tip not to get cool enough.The regulator needs to be replaced.

• Brand Name: CAVITRON BUILT-IN (G139) WITH 66" GRAY CABLE AND STERI-MATE HANDPIECE(DNA
• 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: 19097579
• Report Number: 2424472-2024-00029
• Device Sequence Number: 20786736
• Product Code: ELC
• UDI-Device Identifier: D00388000051
• UDI-Public: D00388000051
• 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): 05/05/2024

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: 8800005
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/05/2024
• 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