MAUDE Adverse Event Report: DENTSPLY LLC SELECT SPS SWVL/RESRV,230VUK/I; SCALER, ULTRASONIC

Catalog Number 81311

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that while a customer was using select sps swvl/resrv,230vuk/i during treatment it is alleged that the cavitron tip was hot and the patient's lip felt a burning sensation.Reportedly, no injury.

Manufacturer Narrative

Unsuccessful attempts to retrieve suspect product for investigation/evaluation have been made and documented.Complaint will be reopened if suspect product or investigation result arrives per (b)(4).

• Brand Name: SELECT SPS SWVL/RESRV,230VUK/I
• 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 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18132936
• MDR Text Key: 328070564
• Report Number: 2424472-2023-00421
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: D003813081
• UDI-Public: D003813081
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 81311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/26/2023
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1