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

Catalog Number 81311

Device Problem Restricted Flow rate (1248)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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 results are not available as of this report.Evaluation results will be submitted as they become available.This mdr submission is a late submission.A capa has been issued.

Event Description

In this event it is reported that select sps swvl/resrv,230vuk/i not enough water coming through handpiece and can not control how much water is coming through.Handpiece is overheating also.

Manufacturer Narrative

Dhr review is not required because the product was returned for evaluation and the customer complaint is a known hazard.Product was evaluated by dentsply sirona uk repair centre.Please refer to the case notes for the repair details.To carry out inspection of unit, found pump filter to be clogged, used one of the filters that came in a bag of ten and tested for functionality , also found handpiece watercontol on its lowest setting.Adjusted and ran unit on test all ok.Failure mode: overheating handpiece.Root cause: defective component/part.Conclusion code: unexpected failure.

• 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: 18534906
• MDR Text Key: 333130450
• Report Number: 2424472-2024-00352
• 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: 01/25/2024

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 Catalogue Number: 81311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/17/2023
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1