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

Catalog Number G123

Device Problems Restricted Flow rate (1248); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

While using a cavitron select with reservoir g123 they allege that they have no water and the handpiece gets hot, no injury resulted.

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.

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
• Type of Device: 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
• MDR Text Key: 340457942
• Report Number: 2424472-2024-00030
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D003813081
• UDI-Public: D003813081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: G123
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1