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

Catalog Number 80395

Device Problems Overheating of Device (1437); Infusion or Flow Problem (2964); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.

Event Description

In this event it is reported that a 30k fsi-sli-10s insert,pkd, that water is not coming out of the tip and causing the machine to overheat.No injury was reported from the alleged event.

Manufacturer Narrative

Investigation results: root cause: other, low water flow.- insert tip has low water flow.Also insert was tested on a digital thermometer i.D.# (b)(4) due date: (b)(6) 2023.The temperature was 102.1° f, no fault found.The specification states are not to exceed 118.4°f.(per frs-9175).Conclusion code: unexpected failure.Returned qty.(b)(4) insert, (b)(4), ga, warranty, test method / gp005-wi02.Inductance: gauge id# (b)(4) , due: (b)(6) 2024, result: 3.19.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: g136 gage id# (b)(4), due date: (b)(6) 2023, set pressure: 35 psi.Water flow: output rate: (b)(4)- 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 has low water flow.Also insert was tested on a digital thermometer i.D.# (b)(4) due date: (b)(6) 2023.The temperature was 102.1° f, no fault found.The specification states are not to exceed 118.4°f.(per frs-9175).Alleged event: confirmed - not confirmed.

• Brand Name: 30K FSI-SLI-10S INSERT,PKD
• Type of Device: 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: 16272332
• MDR Text Key: 308832630
• Report Number: 2424472-2023-00349
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052334/K970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 80395
• Device Lot Number: 00082975
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/30/2023
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1