MAUDE Adverse Event Report: ASI ADVANCED ENDODONTIC SYSTEM; DENTAL DELIVERY UNIT

Model Number 2125

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/02/2016

Event Type  Injury  

Event Description

During surgical dental procedure, the vacuum pump became sluggish and the high speed drill was not operating.The procedure had to be paused but could not be aborted, due to sharp tooth edges that could cause injury to the pt.

• Brand Name: ADVANCED ENDODONTIC SYSTEM
• Type of Device: DENTAL DELIVERY UNIT
• Manufacturer (Section D): ASI ; englewood CO 80112
• MDR Report Key: 6080933
• MDR Text Key: 59396065
• Report Number: MW5065825
• Device Sequence Number: 1
• Product Code: DZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 13