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

Catalog Number 82005

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event it is reported that a 30k fsi-sli-fg-10s ins,pkd insert allegedly was overheating.No injury occurred.

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 has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Root cause: no defect.Both insert was tested on a digital thermometer i.D.#(b)(6)m due date: (b)(6) 2023.The temperature was 86.0°f and 85.8°f, no fault found.The temperature states are not to exceed 118.4°f.(per frs-9175 rev.9, on 4.1).Conclusion code: no failure found.Returned qty.2 inserts, 1.82005, 22214-00080734, jw, warranty test method / sop man.007 rev.9 inductance: gauge id# (b)(4) due: (b)(6) 2024 result: 3.10 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: (b)(6) 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 is good, no fault found.Also, insert was tested on a digital thermometer i.D.#(b)(6) due date: (b)(6)n2023.The temperature was 86.0°f, no fault found.The temperature states are not to exceed 118.4°f.(per frs-9175 rev.9, on 4.1).Alleged event: confirmed - not confirmed.2.82005, 22214-00080734, jw, warranty.Test method / sop man.007 rev.9.Inductance: gauge id# (b)(4) due: 11/30/2024 result: 3.05/ 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: (b)(6) 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 is good, no fault found.Also, insert was tested on a digital thermometer i.D.#6116a due date: 09/30/2023.The temperature was 85.8°f, no fault found.The temperature states are not to exceed 118.4°f.(per frs-9175 rev.9, on 4.1).Alleged event: confirmed - not confirmed.

• Brand Name: 30K FSI-SLI-FG-10S INS,PKD
• Type of Device: 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: 16135396
• MDR Text Key: 308377797
• Report Number: 2424472-2023-00340
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K052334/K970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 82005
• Device Lot Number: 00080734
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/09/2023
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1