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

Model Number G124

Device Problem Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

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.

Event Description

Based on the repair evaluation of a g124 scaler, there was kink in the water supply hose, debris buildup in the water filter, and blockage in the handpiece cable causing restricted water flow.The customer reported that the handpiece was heating up; no injury resulted.

• Brand Name: CAVITRON SELECT SPS ULTRASONIC SCALER
• 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: 9535663
• MDR Text Key: 186733443
• Report Number: 2424472-2019-00207
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/23/2019

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: G124
• Device Catalogue Number: 81324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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