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

Model Number G136

Device Problems Break (1069); Restricted Flow rate (1248); Overheating of Device (1437); Free or Unrestricted Flow (2945)

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 has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

While using a g136 scaler, the unit was overheating and had abnormal water flow and a broken potentiometer; no injury resulted.

Manufacturer Narrative

Abnormal water flow and broken potentiometer.

• Brand Name: CAVITRON PLUS PACKAGE
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 8196686
• MDR Text Key: 131595856
• Report Number: 2424472-2018-00204
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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: 8161425
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1