MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL CAVITRON SELECT SPS ULTRASONIC SCALER; SCALER, ULTRASONIC

Model Number G124

Device Problems Restricted Flow rate (1248); Overheating of Device (1437)

Patient Problems Pain (1994); No Information (3190)

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 using a g124 scaler a cavitron unit was not cooling resulting in overheating.Patients began to feel pain.Also there was much lower consumption of distilled water.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Replaced worn water filter which was restricting the water flow from the pump.Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: CAVITRON SELECT SPS ULTRASONIC SCALER
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• MDR Report Key: 7278678
• MDR Text Key: 100534254
• Report Number: 2424472-2018-00011
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K970123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

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 Model Number: G124
• Device Catalogue Number: 81307
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1