MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL 30K BELLISSIMA FOCUSED SPRAY SLIMLINE INSERT; ULTRASONIC SCALER

Catalog Number 81510

Device Problems Melted (1385); Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

In this event it was reported that two cavitron 30k fsi-sli-1000 inserts melted.Multiple unsuccessful attempts were made to obtain additional information.

Manufacturer Narrative

There has been a previous report received where this malfunction (overheating) 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.This report is for the second device.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.Not returned.

• Brand Name: 30K BELLISSIMA FOCUSED SPRAY SLIMLINE INSERT
• Type of Device: ULTRASONIC SCALER
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; york PA
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st. ; ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4892614
• MDR Text Key: 6828943
• Report Number: 2424472-2015-00036
• 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,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1