MAUDE Adverse Event Report: DENTSPLY LLC 30K FOCUSED SPRAY SLIMLINE FITGRIP ULTRASONIC INSERT - 1000; SCALER, ULTRASONIC

Catalog Number 82008

Device Problem Overheating of Device (1437)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

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.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

While using a 30k fsi-sli-fg-1000 insert, it was overheating.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

The device was evaluated and found to be within specification.Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: 30K FOCUSED SPRAY SLIMLINE FITGRIP ULTRASONIC INSERT - 1000
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 9367480
• MDR Text Key: 186723584
• Report Number: 2424472-2019-00193
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K052334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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 Operator: Health Professional
• Device Catalogue Number: 82008
• Device Lot Number: 19157
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/26/2019
• Initial Date FDA Received: 11/24/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1