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

Catalog Number 81570

Device Problems 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-1000 insert got hot and insert not vibrating.Injury is unknown and no other information is available as of this mdr - additional information pending.

Manufacturer Narrative

While no serious injury resulted in this event, 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.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

Visually inspected and verified the insert has a bend tip.Also was tested on a digital thermometer id #(b)(4).Due date: 08/31/2022.The temperature was 90.4°, is no fault found.The specification sates are not to exceed 118.4°f.(per frs-9175 rev.9, on 4.1).

• Brand Name: 30K FSI-SLI-1000 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: 14073822
• MDR Text Key: 298577787
• Report Number: 2424472-2022-00308
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• 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: 06/08/2022

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: 81570
• Device Lot Number: 00070775
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/29/2022
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1