MAUDE Adverse Event Report: DENTSPLY LLC 30K FSI-PWR-1000 INSERT,PACKED; SCALER, ULTRASONIC

Catalog Number	80799
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There have been previous reports with this or a similar device where this malfunction caused or contributed to a serious injury or required medical/surgical intervention to preclude such.Therefore, this event meets the criteria for a reportable event 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.
Event or Problem Description
In this event it is reported that a 30k fsi-pwr-1000 insert,packed tip broke during use.Reportedly, the tip could not be located and the patient was sent to a&e.There is no follow up on the patient.The outcome is unknown as of this mdr.
Additional Manufacturer Narrative
Return qty.1, 23010, 30k fsi-pwr-1000-45, (b)(6) bul per manufacturing date.30k.Test method / (b)(4).Inductance: gauge id# (b)(4), due: 12/31/2026, result 2.79.Tested on: g130 gage id# (b)(4), due date: 03/31/2025, set pressure: 35 psi.Other visual observation: insert tip is broken after the edm hole.Insert was tested on a digital thermometer i.D.# (b)(4).Due date: 09/30/2025.The temperature was 81.6 °f, no fault found.The specifications state the temperature is not to exceed 118.4°f.(per (b)(4)).

• Brand Name: 30K FSI-PWR-1000 INSERT,PACKED
• 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: 21208838
• Report Number: 2424472-2025-00204
• Device Sequence Number: 14405585
• Product Code: ELC
• UDI-Device Identifier: D003807991
• UDI-Public: D003807991
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: 80799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown