MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON 300 SERIES ULTRASONIC SCALING SYSTEM UNIT; SCALER, ULTRASONIC

Model Number G310

Device Problems Restricted Flow rate (1248); Device Emits Odor (1425); Overheating of Device (1437); Smoking (1585)

Patient Problems Injury (2348); Burn, Thermal (2530)

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 g310 scaler, there was smoke coming out of the unit, and they had low water flow with no insert in the handpiece so the hp was put back into the hp holder.There was an electrical burning smell.The hygienist picked up the hp and burned her index finger.No medical attention was required.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.A dhr review was conducted with no discrepancies noted.

• Brand Name: CAVITRON 300 SERIES ULTRASONIC SCALING SYSTEM UNIT
• 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: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 8213966
• MDR Text Key: 131972533
• Report Number: 2424472-2018-00209
• Device Sequence Number: 1
• Product Code: ELC
• 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: 03/13/2019

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: G310
• Device Catalogue Number: 8270310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 02/18/2019
• Supplement Dates FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1