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

Catalog Number 80395

Device Problems Mechanical Problem (1384); Overheating of Device (1437); Temperature Problem (3022)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event it is reported that 30k fsi-sli-10s insert tip allegedly heats up and rattles.Outcome of this event is unknown as of this mdr.Additional information requested.

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.

Manufacturer Narrative

Visual observation: insert is good, no fault found.Also insert was tested on a digital thermometer i.D.#6116a due date: 09/30/2023.The temperature was 87.4°, no fault found.The specification states are not to exceed 118.4°f.

• 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: 15707719
• MDR Text Key: 307115966
• Report Number: 2424472-2022-00325
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K052334/K970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

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: 80395
• Device Lot Number: 20220428C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/27/2022
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1