MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL 25K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT; SCALER, ULTRASONIC

Catalog Number 80392

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)

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 25k fsi-sli-10s insert, the stacks were not moving and the insert was heating up; no injury resulted.

Manufacturer Narrative

The insert was tested with bobcat pro serial # (b)(4) and was tested for temperature and a reading of 98.1 degrees was recorded at the working area of the insert tip.The insert was tested at 35cc of water flow, the thermometer id # 6112 (cal date 11/08/16 - cal due 11/30/17).In conclusion the complaint for the insert getting hot could not be duplicated and the insert could not be failed for the temperature due to needing a 118.4°f to warrant a failure.

• Brand Name: 25K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6296518
• MDR Text Key: 66569642
• Report Number: 2424472-2017-00004
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80392
• Device Lot Number: 16180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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