MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON JET PLUS TAP-ON (DNA) G137; SCALER, ULTRASONIC

Catalog Number	G137
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
While using a cavitron jet plus g137 they allege that low water flow to handpiece and handpiece is getting hot; no injury resulted.
Additional Manufacturer Narrative
There has been a previous report received where lack of water flow has caused an overheating insert.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
05/29/24 evaluation tech: mjo.Xjv ft control, cable, recep open.Inconsistent activation of wireless foot pedal in second position.Moisture found in powder bowl and air manifold.Clogged duckbill filter causing poor air/powder flow, no batteries in foot pedal.Worn jet-mate nozzle grip.Cracked aux port on bracket board.Could not duplicate customer's complaint.Water flow present.Advise customer to ensure water pressure to unit is at recommended 40psi.Will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.Hpc - 05220.Hp - 04150.

• Brand Name: CAVITRON JET PLUS TAP-ON (DNA) G137
• 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: 19149596
• Report Number: 2424472-2024-00031
• Device Sequence Number: 20694042
• Product Code: ELC
• UDI-Device Identifier: D00381614281
• UDI-Public: D00381614281
• 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): 05/30/2024

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: G137
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/30/2024
• 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