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

Catalog Number 81324

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 select sps g124 they allege that the insert is getting hot.No injury was reported from the alleged event.

Manufacturer Narrative

Rmc: (b)(6) 2024.000 evaluated: meets specifications; contact customer.Could not replicate the compliant, ran unit 30 minutes without test insert or test handpiece getting warm.Recommend inspecting insert(s) being used for any clogging or damaged.No sterimate sent in.Added new sterimate to estimate as precautionary measure.Will replace worn/damaged parts, calibrate and clean unit upon customer approval.Hpc: (b)(6) 2020.

• Brand Name: CAVITRON SELECT SPS G124 GENERATOR(DNA)
• 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: 19195994
• MDR Text Key: 341464891
• Report Number: 2424472-2024-00034
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D00381614241
• UDI-Public: D00381614241
• 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: 05/22/2024

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: 81324
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2024
• 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