MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES G310SCLR (DNA); 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  

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.

Event Description

While the customer was using a cavitron 300 series g310 they allege that they think clogged lines, and said for a while inserts were heating up, now they have no cavitation.No injury was reported from the alleged event.

Manufacturer Narrative

Notes: (b)(6) 24 repair tech: dts w4e water sol,iso valve clogged no water flow due to a clogged water solenoid.Debris buildup in the water supply hose.No operation due to a clog in the handpiece harness tubing.Blockage in the handpiece cable causing restricted water flow.Replaced damaged/worn components and recalibrated unit to factory specs.Qa-tl no handpiece received for evaluation customer is using listerine to clean the lines but not flushing it out completely, causing it to dry out and harden listerine should not be used with this unit, it has sugar in it that clogs up when dry, the whole water system needed to be replaced due to this for the second time in six months.For proper evalation always send in all parts that go along with the unit to be looked at double check all handpieces and inserts used with this unit for any clogging no handpiece, old hdpc (b)(6) 2023, new hdpc (b)(6) 2024.

• Brand Name: CAVITRON 300 SERIES G310SCLR (DNA)
• 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: 19013074
• MDR Text Key: 339033226
• Report Number: 2424472-2024-00025
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D00382703131
• UDI-Public: D00382703131
• 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: 04/24/2024

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: G310SCLR
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2024
• 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