MAUDE Adverse Event Report: DENTSPLY LLC 30K THINSERT FITGRIP ULTRASONIC INSERT; SCALER, ULTRASONIC

Catalog Number 82009

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

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

Event Description

While using a 30k cavitron thinsert fg, the insert was heating up.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Visually inspected and verified insert is clogged has not water or spray pattern.Insert does have vibration and meets spec.Insert has rust in the edm hole and at the base of the tip does not meet spec.The temperature of this insert could not be taken.The insert is clogged.Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: 30K THINSERT FITGRIP ULTRASONIC INSERT
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 7940279
• MDR Text Key: 123375664
• Report Number: 2424472-2018-00156
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82009
• Device Lot Number: 18026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0