MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON SELECT SPS G124 GENERATOR; SCALER, ULTRASONIC

Model Number G124

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

While the customer was using a g124 scaler, they allege that the handpiece, insert and the top of the unit is heating up.No injury was reported from the alleged event.

Manufacturer Narrative

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.After inspection of device component part of water filter need replaced, also verified tuning/calibration.Unit ran at maximum power for extended period without any heating issues.Also, advise customer to inspect inserts for damages/wear and replace as needed, also aftermarket inserts may cause issues as well.

Manufacturer Narrative

Replaced water filter as estimated, also verified tuning/calibration.Unit ran at maximum power for extended period without any heating issues.Advise customer to inspect inserts for damages/wear and replace as needed, also aftermarket inserts may cause issues as well.

• Brand Name: CAVITRON SELECT SPS G124 GENERATOR
• 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: 12972333
• MDR Text Key: 284987894
• Report Number: 2424472-2021-00086
• 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,Followup
• Report Date: 01/21/2022

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: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1