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
Event or Problem Description
While the customer was using a cavitron select sps g124, they allege that the handpiece is overheating.No injury was reported from the alleged event.Investigation found restricted flow and debris causing the overheating.
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.Device was returned and the investigation results are: notes: "06/07/24 repair tech: tl woe hose,tubing,clogged kink in water supply hose, debris buildup in the water filter.Blockage in the handpiece cable causing restricted water flow, worn steri-mate handpiece.Replaced damaged/worn components and recalibrated unit to factory specs.Qa - cn handpiece # old 08172 -- new 202402 handpiece cable # old 05230 -- new 03240.

• 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: 19497585
• Report Number: 2424472-2024-00054
• Device Sequence Number: 7907485
• 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): 06/10/2024

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: 05/14/2024
• Initial Report FDA Received Date: 06/10/2024
• 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