MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON PLUS ULTRASONIC SCALER WITH TAP-ON TECHNOLOGY; SCALER, ULTRASONIC

Model Number G136

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)

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.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 g136, the unit was leaking at all times and the handpiece is overheating; no injury resulted.

Manufacturer Narrative

Unit arrived with no filter in water supply line.Unknown how long it was run without a filter.Debris from unfiltered water damaged the water regulator causing it to leak.It appeared that unit was run with water control on handpiece cable turned all the way down to stop the leaking when not in use.Operating with the water control turned all the way down will cause the sterimate to overheat.Replaced water regulator and sterimate.Flushed water supply line and installed water filter.Calibrated and checked all functions.

• Brand Name: CAVITRON PLUS ULTRASONIC SCALER WITH TAP-ON TECHNOLOGY
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 9073478
• MDR Text Key: 186607461
• Report Number: 2424472-2019-00138
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K052334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

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: G136
• Device Catalogue Number: 8184001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1