MAUDE Adverse Event Report:; DENTAL DRILL

Model Number M4B-28/970

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 04/07/2014

Event Type  No Answer Provided  

Event Description

The surgeon was drilling in the patient's mouth (right mandible).The drill overheated causing a burn to the patient's lip.During the ostectomy, the surgeon noticed the handpiece of the drill became unusually hot.He stopped the procedure only to discover a burn had occurred on the right mucosal surface of the lip associated with this equipment failure.What was the original intended procedure.Outpatient removal of teeth (bony impacted 17 & 32) as necessary and jaws cysts under general anesthesia.

Manufacturer Narrative

This device reported by (b)(6) that caused the burn on the patient's lip is not an aseptico device.She incorrectly identified the wrong part.It was the handpiece that caused the burn, not the motor.The handpiece is not manufactured by aseptico but by nsk america.We would like this report against our motor removed from publication.I am asking (b)(6) to send in a corrected report to identify the correct device that caused the burn, but i don't know if she will take her time to do so.

• Type of Device: DENTAL DRILL
• Manufacturer Contact: cherie tregoning ; 8333 216th st., s.e.; woodinville, WA 98072 ; 4254873157
• MDR Report Key: 3853046
• MDR Text Key: 4685153
• Report Number: 3017604-2014-00001
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/09/2014

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?: No
• Device Operator: Other
• Device Model Number: M4B-28/970
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 112