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

Catalog Number	G137
Medical Device Problem Codes	Restricted Flow rate (1248); Overheating of Device (1437); No Flow (2991)
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 they have minimal water and the handpiece is heating up, 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
Root cause: emh hp;cable,conn/gun cable damaged.Debris buildup in the handpiece cable and leaking water around the water turn knob continuous water leaking due to debris buildup in the water system not allowing the solenoid to close completely.Jet-mate has a bent contact pin.Manifold has bad regulation resulting in inconsistent powder flow.Cracked powder bowl (has a different screw that is going through the top cover of powder bowel).Baffle is damaged.No operation with the wireless foot pedal.No powder flow due to a clogged y-fitting.Debris build in the water filter.Note: will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.(this unit looks like it has been previously open and worked on).

• 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: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18564643
• Report Number: 2424472-2024-00003
• Device Sequence Number: 17856978
• 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): 02/13/2024

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: 01/23/2024
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/13/2024
• 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