MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON SELECT RESERVOIR(DNA) G123; SCALER, ULTRASONIC

Catalog Number	G123
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 a cavitron select with reservoir g123 they allege that they have no water and the handpiece gets 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
"04/18/24 evaluation tech: tl emn hp; cable, conn/gun cable kink/pinch/twist g124 -the poor water flow due to twisted handpiece cable causing handpiece gets hot.Worn steri-mate handpiece.Recommend checking all inserts being used are not worn, corroded, damaged and /or clogged and handpiece cable's lavage control is properly adjusted also, follow instructions to bleed the air from the handpiece when installs insert.Make sure screw the cap clockwise to create an airtight seal when using reservoir pump.G123 - no issues found.Unit operates properly.Will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.Handpiece # 202110 handpiece cable # 11210.

• Brand Name: CAVITRON SELECT RESERVOIR(DNA) G123
• 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: 19132624
• Report Number: 2424472-2024-00030
• Device Sequence Number: 6891334
• Product Code: ELC
• UDI-Device Identifier: D003813081
• UDI-Public: D003813081
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970123
• 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: G123
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• 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