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

Catalog Number	82006
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-fg-10l ins, pkd got hot during use.No injury reported.
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 21cfr 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
Failure mode: overheating insert.Root cause: tip/nozzle corroded (rust) 1) tip corroded (rust) / also insert was tested on a digital thermometer i.D.# (b)(6), due date: 09/30/2023.The temperature was 92.7° f, no fault found.The specification states are not to exceed 118.4°f.(per (b)(4)).2) tip corroded (rust) / also insert was tested on a digital thermometer i.D.# (b)(6), due date: 09/30/2023.The temperature was 89.5° f, no fault found.The specification states are not to exceed 118.4°f.(per (b)(4)).Returned qty.2 inserts, 1.80396, 22236-00081988, 54, bul.Test method / gp005-wi02.Inductance: gauge id# 5349, due: 11/30/2024, result: 3.20.¿ 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: g136 gage id# (b)(4), due date: 09/30/2023, 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 rusty.Also insert was tested on a digital thermometer i.D.#6116a due date: 09/30/2023.The temperature was 92.7° f, no fault found.The specification states are not to exceed 118.4°f.(per frs-9175).Alleged event: ¿ confirmed - ¿ not confirmed.¿ 2.80396, 22236-00081988, 54, bul.Test method / gp005-wi02 inductance: gauge id# 5349 due: 11/30/2024 result: 3.20 ¿ 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: g136 gage id# 9626-2 due date: 09/30/2023 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 rusty.Also insert was tested on a digital thermometer i.D.#6116a due date: 09/30/2023.The temperature was 89.5° f, no fault found.The specification states are not to exceed 118.4°f.(per frs-9175).Alleged event: ¿ confirmed - ¿ not confirmed.

• Brand Name: 30K FSI-SLI-FG-10L 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17548043
• Report Number: 2424472-2023-00399
• Device Sequence Number: 6676537
• Product Code: ELC
• UDI-Device Identifier: D003820061
• UDI-Public: D003820061
• 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): 11/02/2023

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 Catalogue Number: 82006
• Device Lot Number: 00081988
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/11/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown