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

Catalog Number 82006

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event it is reported that a 30k fsi-sli-fg-10l ins,pkd, they allege got hot.No injury reported.

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.

Manufacturer Narrative

Returned qty.(b)(4) inserts, 1.82005, 18214-0009958, ic, bul test method / gp005-wi02.Inductance: gauge id# 5349 due: (b)(6) 2024 result: 3.01.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: (b)(6) 2023 set pressure: 35 psi.Water flow: output rate: (b)(4) 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.Insert was tested on a digital thermometer i.D.#6116a due date: (b)(6) 2023 and the temperature was 82.8°f is good.The specification states are not to exceed 118.4°f (per frs-9175).Alleged event:, confirmed - not confirmed.2.80395, 1109, fc, bul test method / gp005-wi02 inductance: gauge id# 5349 due: (b)(6) 2024 result: 3.00 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: (b)(6) 2023 set pressure: 35 psi water flow: output rate: (b)(4) 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.Insert was tested on a digital thermometer i.D.#6116a due date: (b)(6) 2023 and the temperature was 84.1°f is good.The specification states are not to exceed 118.4°f (per frs-9175).Alleged event: confirmed - not confirmed.Root cause: no defect (aft0140).No defect (qty.2).Both inserts was tested on a digital thermometer i.D.#6116a due date: (b)(6) 2023.The temperature was on inserts; 1.82.8°f.2.84.1°f.Both inserts are good.The specification states are not to exceed 118.4°f (per frs-9175).

• Brand Name: 30K FSI-SLI-FG-10L 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: 16213857
• MDR Text Key: 308495840
• Report Number: 2424472-2023-00343
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K052334/K970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 82006
• Device Lot Number: 18214 & 1109
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/17/2023
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1