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

Catalog Number 81551

Device Problems Overheating of Device (1437); 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, the insert was getting hot.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the patient outcome.The insert was inspected and found to be 99% clogged.The insert was not tested for temperature due to being 99% clogged.After testing the insert was found to have a gel type substance clogging the insert.The insert was unclogged and temperature tested and measured 90.2.The insert was tested using a g-136 unit at 35cc of water flow, the test unit # was g136-01906, thermometer id # (b)(4) (cal date (b)(6) 2016 - cal due (b)(6) 1207).This insert shows multiple uses and wear on the insert tip, also no substance of this type is used during the manufacturing of this product.In conclusion the complaint for the insert getting hot has failed for having no water flow caused by hardened medicament debris.

• Brand Name: 30K THINSERT ULTRASONIC INSERT
• 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: 6983424
• MDR Text Key: 91096727
• Report Number: 2424472-2017-00138
• 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: 11/29/2017

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: 81551
• Device Lot Number: 17076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 10/31/2017
• Supplement Dates FDA Received: 11/29/2017
• 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