MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL CAVITRON STERI-MATE DETACHABLE STERILIZABLE HANDPIECE; SCALER, ULTRASONIC

Catalog Number 78688

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problems No Consequences Or Impact To Patient (2199); Superficial (First Degree) Burn (2685)

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.This report is for the student.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

A dental student was using a g139 scaler without incident on a patient for approximately twenty minutes.When she completed her task, she removed her foot from the foot control and placed her ultrasonic back into its unitized holder.The student stated that the handle was not warm when she placed it back in its holder.Within seconds, she noticed smoke, or a fine mist, coming out of the tip of the insert.The student touched the tip to check it and found that it was hot to the touch but did not burn her.The student asked her professor to come check the handle/insert.When the professor touched the handle she found that it was hot enough that it burnt her gloved hand.The burn was classified by a nurse as first degree and care instructions were given to the professor.

Manufacturer Narrative

After a visual inspection, first i noticed the hp is from 2006, (old hp 11 years old).I mentioned that to the customer, then, i took pictures of the g139 installation and proceeded with the assessment.I let the unit run for at least five minutes full power and half way water flow just to see if the hp got hot, i was not able to duplicate a hot hp, but when i stepped off of the footswitch, i noticed that the air/electrical switch did not retract immediately, it stayed engaged for a few seconds causing the hp to remain running, it stopped when i pressed the footswitch for four to five consecutive times, after that, the unit began to operate without any problem, i was trying to duplicate the problem that i just experienced but i was not able to do it again, i proceeded to check voltage while the unit was idle, when it was running and also when it was loaded, all the readings were within specs.

• Brand Name: CAVITRON STERI-MATE DETACHABLE STERILIZABLE HANDPIECE
• 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: 6965367
• MDR Text Key: 90292136
• Report Number: 2424472-2017-00134
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023697
• 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: 78688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• 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