MAUDE Adverse Event Report: DENTSPLY LLC PROPHY-JET,115V G138,PACKED(DNA); SCALER, ULTRASONIC

Catalog Number	8195001
Medical Device Problem Codes	Restricted Flow rate (1248); 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 prophy - jet g138 they allege that they have low water pressure and the handpiece is getting hot, no injury resulted.
Additional Manufacturer Narrative
Hpc# 02220.Sterimate# 202202.W2e reg, needle valve, hp flow cntrl clogged.No water flow due to a blockade in the hp cable.Cracked auxiliary foot pedal connector on the power drive board.Powder buildup in the bowl and cap threads causing an air leak flattened and pinched tubing.Powder bowl cleaned and retubed.Replaced worn/damaged parts and recalibrated to the manufacturing specifications qa by (b)(4).Note: no water hose sent in for evaluation.Dhr review is not required because the product was returned for evaluation and the customer complaint is a known hazard.Customer complaints are monitored during monthly psc meetings.The failure mode mentioned in this complaint is also identified as a potential hazard in the corresponding risk management file.Therefore, no additional action is necessary.

• Brand Name: PROPHY-JET,115V G138,PACKED(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: 20249689
• Report Number: 2424472-2024-00078
• Device Sequence Number: 12588080
• Product Code: ELC
• UDI-Device Identifier: D00381950011
• UDI-Public: D00381950011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130862
• 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): 12/31/2024

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: 8195001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 12/31/2024
• 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