MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES G310SCLR; SCALER, ULTRASONIC

Catalog Number G310SCLR

Device Problems Overheating of Device (1437); No Flow (2991)

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

Event Type  malfunction  

Event Description

While using a cavitron 300 series g310, they allege that water is not running through and the handpiece is getting 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

Edz dsp/if/ic/scan board shorted screen does not show power setting.Presetting button shows 00 on all of them.Debris buildup in the water filter.Replaced damaged/worn components and recalibrated unit to factory specs.Tech:water flow checked fine 5cc on min and 70cc on max which is good.No sterimate received for evaluation.

• Brand Name: CAVITRON 300 SERIES G310SCLR
• 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: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18118451
• MDR Text Key: 327909182
• Report Number: 2424472-2023-00053
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D00382703121
• UDI-Public: D00382703121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150535
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G310SCLR
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• 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