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

Catalog Number	81311
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that a select sps swvl/resrv, 230vuk/i is alleged to have overheated and no water flow.No injury occurred.
Additional Manufacturer Narrative
Dhr review is not required because the product was returned for evaluation, and the described failure mode is a known hazard.The repair notes are listed in the case notes section.Engineer's findings: 'unit set up and evaluated, upon inspection the waterline was found to contain a film of excess medicaments that was coated on the inside of the tubing, this film was also prevalent in the plastic tubing connecting the water regulator to the handpiece lead connector.(please see attached photo).Both the waterline assembly and tubing were replaced.Water regulator was faulty as the pressure inside the handpiece could not be adjusted to the recommended 22psi, a new regulator was fitted to meet repair requirement.Water fitting on the handpiece lead socket was found to be pitted with the brass plating starting to wear off, water would also not flow through the lead as it was blocked, a new lead was supplied to meet repair specification.'.

• Brand Name: SELECT SPS SWVL/RESRV,230VUK/I
• Common Device Name: 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 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 23050399
• Report Number: 2424472-2025-00252
• Device Sequence Number: 21210388
• Product Code: ELC
• UDI-Device Identifier: D003813021
• UDI-Public: D003813021
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K970123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/11/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown