MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON TOUCH ULTRASONIC SCALING SYSTEM; SCALER, ULTRASONIC

Model Number G1000

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr 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 g1000 scaler, inserts were heating up; no injury resulted.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.Dhr reviewed and there were no issues with the dhr.1 deviation was in place for a labelling change but this would not impact the functionality of the product.

• Brand Name: CAVITRON TOUCH ULTRASONIC SCALING SYSTEM
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 7775848
• MDR Text Key: 117264404
• Report Number: 2424472-2018-00120
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K150535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

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: G1000
• Device Catalogue Number: 8250001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/12/2018
• Initial Date FDA Received: 08/12/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1