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 results are not available 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 no water coming through.No injury.
Additional Manufacturer Narrative
Unit set up and evaluated, upon inspection the sterimate was found to be defective, a continuity test revealed there was an open circuit in the handpiece (no continuity) and so a new one was supplied and tested to resolve this issue.Cap on the water bottle was missing however there was a fine film of residue on the inside of the bottle which could not be removed, a new bottle was supplied to correct this.Both footswitches sent in were found to be working intermittently, two new pedals have been supplied and tested to meet repair requirements.One of the contact pins inside the pumps handpiece lead connector was pushed in, this will cause continuity issues and so a new wire harness was fitted to maintain good continuity with the scaler.A new pump bumper/seal was fitted as the former one was very discolored and worn.Water regulator in the main control unit was faulty as pressure inside the handpiece could not be adjusted to the required 22psi, customer was advised but declined a new regulator as they only used the scaler with the pump unit/bottle.Hairline crack detected at the back of the top case but not effecting the structural integrity of the housing.Repair, calibration and functionality checks carried out, unit running ok.Dhr review is not required because the product was returned for evaluation, and the described failure mode is a known hazard.The device itself is beyond its intended service life (manufactured prior to 2016), and the repairs noted are typical and expected for a system of this age that remains in active use.

• 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: 24316874
• Report Number: 2424472-2026-00529
• Device Sequence Number: 4862902
• 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): 05/05/2026

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: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/10/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown