MAUDE Adverse Event Report: DENTSPLY LLC 30K FSI-SLI-FG-1000 INS,PKD; SCALER, ULTRASONIC

Catalog Number	82008
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a 30k fsi-sli-fg-1000 ins,pkd allegedly got hot during use.No injury occurred.
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
Event reported to bunnell 04/18/2025.Based on initial report, this event was determined to be not reportable as there was no patient injury reported.User facility report (b)(4) received 04/25/2023.Initial report submitted 05/25/2023 in response to the user facility report.Investigation has been completed.The reported symptom (flood water on the circuit, no injury to patient) could be verified and was reproduced exactly as reported.An internal inspection of the hfv found the right support bracket severely bent.The right support bracket (p/n: 03015-00) was replaced.The contact block (p/n: 03191-00), 2 receptacle solder cups (p/n: 00952-00), 7 receptacle solder cups (p/n: 00951-00), 7 probe contact spring (p/n: 00951), and 2 probe contact springs (p/n: 03307-00) were also replaced which restored normal operation.The hfv and pb were thoroughly inspected, tested and operationally verified to have no additional problems.The system stabilized at the default controls settings with all monitored values remaining very stable with very little fluctuations.The hfv was fully serviced and passed all applicable testing requirements.The damage observed was most likely due to mechanical impact due to droppage, crashing into a hard surface, etc.

• Brand Name: 30K FSI-SLI-FG-1000 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: 16973044
• Report Number: 2424472-2023-00375
• Device Sequence Number: 6723693
• Product Code: ELC
• UDI-Device Identifier: D003820081
• UDI-Public: D003820081
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 07/31/2023

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: 82008
• Device Lot Number: 23058
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/12/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown