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

Catalog Number	80392
Medical Device Problem Codes	Overheating of Device (1437); No Flow (2991)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a 25k fsi-sli-10s insert, pkd tip got really hot and burned the lip of a patient.The patient required no medical attention.
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.
Additional Manufacturer Narrative
Return qty.(b)(4), 25k fsi-sli-10s-ka, 00095618 bul.25k test method / gp005-wi02.Inductance: gauge id# 5349, due: 11/30/2024, result: 3.16, 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# 9625, due date: 06/30/24, 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.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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 19764748
• Report Number: 2424472-2024-00384
• Device Sequence Number: 18278239
• Product Code: ELC
• UDI-Device Identifier: D003803921
• UDI-Public: D003803921
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 10/11/2024

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: 80392
• Device Lot Number: KA00095618
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown