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

Model Number G124

Device Problem Overheating of Device (1437)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

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 was not returned for evaluation.However, the serial number was provided and a dhr review is planned.The results will be submitted as they become available.

Event Description

While using a g124 scaler, there was no vibration and the tip was heating up; no injury resulted.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.

• Brand Name: CAVITRON SELECT SPS ULTRASONIC SCALER
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york, pa
• MDR Report Key: 10463728
• MDR Text Key: 205954481
• Report Number: 2424472-2020-00053
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

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: 81324
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1