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

Model Number G119

Device Problems Restricted Flow rate (1248); Vibration (1674); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

While using a g119 scaler, there was warm water flow and not enough power; no injury.It is unknown if "not enough power" is referring to vibration, water flow, or both.Additionally, the reference to warm water flow could be from the insert and could be caused by the insert overheating.

Manufacturer Narrative

Blockage in the handpiece cable causing restricted water flow, corroded contact pins on the steri-mate handpiece.No water flow due to rust buildup in the solenoid preventing proper operation, poor water flow regulation.Cabinet is cracked.Missing feet.

• Brand Name: CAVITRON SPS ULTRASONIC SCALER
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 9203255
• MDR Text Key: 186716494
• Report Number: 2424472-2019-00150
• 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: 12/20/2019

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: G119
• Device Catalogue Number: G119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1