MAUDE Adverse Event Report: DENTSPLY LLC 30K FSI-SLI-10L INSERT,PKD; SCALER, ULTRASONIC

Model Number	80396
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that 30k fsi-sli-10l insert,pkd allegedly got hot and reportedly little water comes out during use.No injury occurred.
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 results are not available as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Returned qty.1 insert, 80396, 22236-00081988, 54, test method / gp005-wi02 inductance: gauge id# 5349 due: (b)(4) 2024 result: 3.12.Tested on: g136 gage id# 9626-2 due date: (b)(6) 2023 set pressure: 35 psi.Water flow: output rate: 35 psi - meets spec.Other visual observation: insert is good, no fault found.Also insert was tested on a digital thermometer i.D.#6116a due date: (b)(6) 2023.The temperature was 85.8° f, no fault found.The specification states are not to exceed 118.4°f.(per frs-9175).

• Brand Name: 30K FSI-SLI-10L INSERT,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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17286501
• Report Number: 2424472-2023-00393
• Device Sequence Number: 20389269
• Product Code: ELC
• UDI-Device Identifier: D003803961
• UDI-Public: D003803961
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/08/2023

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 Model Number: 80396
• Device Catalogue Number: 80396
• Device Lot Number: 00081988
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/06/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown