MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON PLUS TAP-ON(DNA) G136; SCALER, ULTRASONIC

Catalog Number G136

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

While using a cavitron plus g136 they allege that they had no water flow and the handpiece is heating up,no injury resulted.

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.

Manufacturer Narrative

(b)(6) 2024 cn hpc#hp# w4e water sol,iso valve clogged heavy debris buildup in the water solenoid so the water system causing poor water flow and low pressure.Air manifold leaking, clogged duckbill filter, deteriorated and pinched tubing.Leaked air cap.Low batteries, worn battery door and pad on the foot pedal.Will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.Note: no j mate received for evaluation and not included in the estimate.

• Brand Name: CAVITRON PLUS TAP-ON(DNA) G136
• 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: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18776792
• MDR Text Key: 336525605
• Report Number: 2424472-2024-00015
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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 Catalogue Number: G136
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1