MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT; SCALER, ULTRASONIC

Catalog Number 80395

Device Problems Leak/Splash (1354); Overheating of Device (1437)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, 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 21 cfr 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 fsi-sli-10s insert, the insert was leaking and hot after use; no injury resulted.

Manufacturer Narrative

The returned insert received from the practice was tested in the qa lab for the complaint of the insert is getting hot.The inserts was inspected and tested, the insert was tested for temperature and a maximum reading of 93.8 degrees was recorded.The insert was tested using a g-136 unit at 35cc of water flow, the test unit # was (b)(4), thermometer id # (b)(4) (cal date (b)(6) 2016 - cal due (b)(6) 2017).The insert has a severe leak at the distal from aggressive deflashing.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.The insert can be deemed as failing for the leak issue.

• Brand Name: 30K 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: 6472593
• MDR Text Key: 72412599
• Report Number: 2424472-2017-00031
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052334
• 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: 05/15/2017

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: 80395
• Device Lot Number: 16299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• 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