MAUDE Adverse Event Report: DENTSPLY LLC 25K FSI-SLI-10S INSERT,PKD; SCALER, ULTRASONIC

Catalog Number 80392

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

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported by the customer that the insert "feels like they are getting too hot", they returned the device.At this time unknown of any injury to patient.

Manufacturer Narrative

Evaluation found the insert was clogged.

• Brand Name: 25K 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: 12979360
• MDR Text Key: 284824139
• Report Number: 2424472-2021-00186
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033705
• 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: 02/23/2022

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: 80392
• Device Lot Number: 20342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/26/2021
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 11/26/2021
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1