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

Catalog Number G136

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

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.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 the customer was using a cavitron plus g136 they allege that the unit is overheating with all inserts and sterimates.No injury was reported from the alleged event.

Manufacturer Narrative

Notes: slg, warranty, unit is overheating with all inserts and all sterimates.(b)(6).Emailed by (b)(6).Loaner.Sak w4h customer states hp is heating up, found no such issue, ran unit with water flow set at 35 cc/min using fsi-10 insert on maximum power for extended period with no heating as alleged just normal warmth, problem is most likely with customers inserts which were not sent with unit or not sufficient water flow.Did find water solenoid/regulator did not maintain set pressure and would increase in pressure, this however did not effect flow.Replaced solenoid with new long with installation of water filter.Units tuning/calibration was verified and all functions tested without issue qa-mo.No aux cable with unit.Hpc 04230, sterimate 202301.

• 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: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18826467
• MDR Text Key: 337084286
• Report Number: 2424472-2024-00016
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D00381614251
• UDI-Public: D00381614251
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• 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
• Date Manufacturer Received: 02/29/2024
• 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