MAUDE Adverse Event Report: DENTSPLY LLC 25K FSI-SLI-10S INSERT,PKD; SCALER, ULTRASONIC

Model Number	80392
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable 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 a 25k fsi-sli-10s insert, pkd during use water would not flow out of insert and the insert is heating up.No injury occurred.
Additional Manufacturer Narrative
Root cause: tip / nozzle clogged (ins105).Tip clogged.Insert has no water flow, clogged and cannot test on thermometer.Conclusion code: unexpected failure.Returned qty.1 insert, 80392, 22319-00086970, gf, warranty test method / gp005-wi02 inductance: gauge id# (b)(6) due: (b)(6) 2024 result: 3.19 meets spec does not meet spec n/a tip condition: - meets spec does not meet spec n/a stack condition meets spec does not meet spec n/a tested on: g130 gage id# (b)(6) due date: 06/30/2023 set pressure: 35 psi water flow: output rate: 35 psi - meets spec does not meet spec n/a spray pattern: - meets spec does not meet spec n/a water leak: hp sealing ring proximal ring distal ring seam leak n/a vibration: - meets spec does not meet spec n/a grip condition: meets spec does not meet spec n/a other visual observation: insert tip is clogged, no water flow.Insert has no water flow, clogged and cannot test on thermometer.Alleged event: confirmed - not confirmed.

• Brand Name: 25K FSI-SLI-10S 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: 16637180
• Report Number: 2424472-2023-00362
• Device Sequence Number: 5980057
• Product Code: ELC
• UDI-Device Identifier: D003803921
• UDI-Public: D003803921
• Combination Product (Y/N): N
• PMA/510(K) Number: K033705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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: 80392
• Device Catalogue Number: 80392
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/28/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown