MAUDE Adverse Event Report: DENTSPLY LLC 30K FSI-SLI-FG-10S INS,PKD; SCALER, ULTRASONIC

Catalog Number	82005
Medical Device Problem Codes	Restricted Flow rate (1248); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 30k fsi-sli-fg-10s ins,pkd insert got hot during use.No injury was reported from the alleged event.
Additional Manufacturer Narrative
Return qty.1, 22103, 30k fsi-sli-10s fg-js, 00074692 bul.30k.Test method / gp005-wi02.Inductance: gauge id# 5349, due: 11/30/2024, result 3.03.Tested on: g130 gage id# 9626-2, due date: 03/31/2024, set pressure: 35 psi.Water flow: output rate: 35 psi.Other visual observation: insert tip is clogged.Insert was tested on a digital thermometer i.D.#6116a.Due date:09/30/2024.The temperature was 78.4°f, no fault found.The specifications state the temperature is not to exceed 118.4°f.(per (b)(4)).

• Brand Name: 30K FSI-SLI-FG-10S INS,PKD
• 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: 19355992
• Report Number: 2424472-2024-00369
• Device Sequence Number: 17734345
• Product Code: ELC
• UDI-Device Identifier: D003820051
• UDI-Public: D003820051
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052334/K970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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
• Device Catalogue Number: 82005
• Device Lot Number: 22103
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown