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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a 30k fsi-pwr-1000 insert, packed alleged the tip broke during use in patient's mouth.Attempted to retrieve the broken part from patient but patient began to swallow and tongue movement caused movement of broken tip.Suction was placed in the area where the tip was broken.Unsure if patient swallowed tip or if tip got suctioned.Patient reported no trouble breathing or swallowing.A panoramic radiograph showed no evidence of broken tip in patient's mouth.Patient was directed to proceed to ed for imaging to confirm if broken tip had not been aspirated or ingested.Patient was evaluated, chest and abdominal radiographs reviewed and no identifiable foreign body was found.
Additional Manufacturer Narrative
Since this incident 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 was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Additional Manufacturer Narrative
Cavitron tip was disposed of in sharps container and will not be returned to be evaluated.

• 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: 24161861
• Report Number: 2424472-2026-00506
• Device Sequence Number: 9019642
• Product Code: ELC
• UDI-Device Identifier: D003807991
• UDI-Public: D003807991
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052334
• 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): 04/30/2026

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/12/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown