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

Catalog Number 81551

Device Problems Restricted Flow rate (1248); Overheating of Device (1437); Insufficient Flow or Under Infusion (2182); Temperature Problem (3022)

Patient Problem 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 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, it was heating up and had low water flow.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Visually inspected and verified the insert is slightly clogged.The temperature was taken with a digital thermometer id# 16116a due date: 07/31/2018.The temp is 110 f.This temperature meets spec.Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: 30K THINSERT ULTRASONIC INSERT
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• MDR Report Key: 7518957
• MDR Text Key: 108494682
• Report Number: 2424472-2018-00072
• 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: 07/12/2018

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: 81551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1