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

Catalog Number	81324
Medical Device Problem Code	Restricted Flow rate (1248)
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.Investigation results: 10/02/24 repair tech: (b)(4).000 evaluated,meets specifications;contact customer.Replaced damaged/worn components and recalibrated unit to factory specs.G123.Ezz pwr cd,wire harn shorted.Debris buildup in the water filter.Replaced damaged/worn components and recalibrated unit to factory specs.
Event or Problem Description
While using a cavitron select sps g124 they allege that they are having water flow issues and the handpiece heats up.No injury resulted.

• 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: 20352931
• Report Number: 2424472-2024-00084
• Device Sequence Number: 20833061
• 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
• Report Date (Section B): 10/02/2024

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): Initial
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/02/2024
• 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