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

Model Number 82009

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

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

While using a 30k cavitron thinsert-fg, the insert was overheating; no injury resulted.

Manufacturer Narrative

Visually inspected and verified the insert has water and vibration.The insert was tested on a digital thermometer gauge # (b)(4) due date: (b)(6) 2019 the temperature is 89.8° degrees.Specification states not to exceed 118.4° f (per frs-9175 rev.9).Insert has a bend in the lamination stack does not meet spec.

• 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: 8181167
• MDR Text Key: 131015497
• Report Number: 2424472-2018-00208
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

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 Model Number: 82009
• Device Catalogue Number: 82009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 02/14/2019
• Patient Sequence Number: 1