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

Model Number	82005
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
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 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 30k fsi-sli-fg-10s ins, pkd overheated during use.No injury occurred.
Additional Manufacturer Narrative
Investigation results: returned qty.( b)(4) inserts, 1.82005, 22291-00085016, gd, bul, test method / gp005-wi02, inductance: gauge id#: 5349, due: 11/30/2024, result: 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: 03/31/2023, 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 87.0° f, no fault found.The specification states are not to exceed 118.4°f.(per frs-9175).Alleged event: confirmed / not confirmed, 2.82005, 22291-00085016, gd, bul, test method / gp005-wi02, inductance: gauge id#: 5349, due: 11/30/2024, result: 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: 03/31/2023 , 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 90.1° f, no fault found.The specification states are not to exceed 118.4°f.(per frs-9175).Alleged event: confirmed / not confirmed.3.82004, 22300-00085643, 43, warranty, test method / gp005-wi02, inductance: gauge id#: 5349, due: 11/30/2024, result: 3.12, 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: 03/31/2023, 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 86.8° f, no fault found.The specification states are not to exceed 118.4°f.(per frs-9175).Alleged event: confirmed / not confirmed, 4.82004, 22300-00085643, 43, warranty, test method / gp005-wi02, inductance: gauge id#: 5349, due: 11/30/2024, result: 3.15, 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: 03/31/2023, 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 88.9° f, no fault found.The specification states are not to exceed 118.4°f.(per frs-9175).Alleged event: confirmed / not confirmed.5.82004, 22305-00086045, 44, warranty, test method / gp005-wi02, inductance: gauge id#: 5349, due: 11/30/2024, result: 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: 03/31/2023, 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: returned a new unopen packaged insert.Alleged event: confirmed / not confirmed.

• Brand Name: 30K FSI-SLI-FG-10S 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: 16750390
• Report Number: 2424472-2023-00372
• Device Sequence Number: 16985545
• Product Code: ELC
• UDI-Device Identifier: D003820051
• UDI-Public: D003820051
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K052334/K970
• 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): 07/13/2023

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: 82005
• Device Catalogue Number: 82005
• Device Lot Number: 22291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/14/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown