MAUDE Adverse Event Report: DENTSPLY LLC CAVITRON SELECT SPS G124; SCALER, ULTRASONIC

Catalog Number	81324
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
While using a cavitron select sps g124 they allege that no water running and handpiece is hot, no injury resulted.
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.
Additional Manufacturer Narrative
Evz potentiometer shorted.Short in the power potentiometer causing the scale power to stay on highest level.Debris buildup in the water filter.Replaced damaged/worn components and recalibrated unit to factory specs.Qa-tl: could not duplicate the complaint of no water and the handpiece getting hot.Check your inserts for any damage or clogging.Make sure only 30k denstply sirona inserts are being used with this unit, any other brand can cause issues.Handpiece 01/2023, hdpc 12/2022.Notes: 04/11/24 repair tech: (b)(4).Evz potentiometer shorted.Short in the power potentiometer causing the scale power to stay on highest level.Debris buildup in the water filter.Replaced damaged/worn components and recalibrated unit to factory specs.Qa-tl: could not duplicate the complaint of no water and the handpiece getting hot.Check your inserts for any damage or clogging.Make sure only 30k denstply sirona inserts are being used with this unit, any other brand can cause issues.Handpiece 01/2023, hdpc 12/2022.Within warranty? no.

• Brand Name: CAVITRON SELECT SPS G124
• 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 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18948668
• Report Number: 2424472-2024-00022
• Device Sequence Number: 7050454
• Product Code: ELC
• UDI-Device Identifier: D00381614241
• UDI-Public: D00381614241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 81324
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown