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

Catalog Number	82005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.Investigation results: return qty.1, 22321, 30k fsi-sli-10s-gf, 00087051 bul 30k.Test method / gp005-wi02 inductance: gauge id (b)(4) due: (b)(6) 2024 result 3.05.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 (b)(4) due date: on (b)(6) 2024 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 broken at the edm hole.Alleged event: confirmed - not confirmed.
Event or Problem Description
In this event it is reported that a 30k fsi-sli-fg-10s ins,pkd tip broke and patient swallowed the broken tip.Patient was sent to emergency room to locate tip.

• 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20133988
• Report Number: 2424472-2024-00392
• Device Sequence Number: 15234047
• Product Code: ELC
• UDI-Device Identifier: D003820051
• UDI-Public: D003820051
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/04/2024

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: 82005
• Device Lot Number: 00087051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/15/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown