MAUDE Adverse Event Report: ENGLE DENTAL SYSTEMS, LLC E300 LED CEILING MOUNTED DENTAL LIGHT SYSTEM; LIGHT, OPERATING, DENTAL

Model Number P024617

Device Problems Installation-Related Problem (2965); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2020

Event Type  Injury  

Event Description

Ceiling light installed by 3rd party equipment dealer ((b)(6) dental services) fell from installation point while in use at (b)(6) dental, (b)(6).A dental assistant and pt caught the falling light mid-air preventing an injury.Upon investigation, key mounting instructions and parts were not used in the installation of the light, clearly instructions on setup and use were not followed.Factory directed service inspection was provided after notification of incident.During the inspection the findings were clear that the equipment was installed improperly.A warning was provided to both (b)(6) dental and (b)(6) dental services that the equipment was originally installed incorrectly and posed a hazard.A second factory directed installer went through the office inspecting equipment, retrieved the damaged light, and noted the improper installation of the damaged light along with another light still in use.Both the factory directed installer and engle dental have provided advanced dental a warning the equipment needs to be taken out of service or re-installed under proper supervision.Engle dental has instructed dental practice to remove all lights from practice use or have them properly installed by a trained and knowledgeable service tech.As of the report date, (b)(6) dental practice mgmt and drs have not complied with removal or proper installation warnings.Fda safety report id# (b)(4).

• Brand Name: E300 LED CEILING MOUNTED DENTAL LIGHT SYSTEM
• Type of Device: LIGHT, OPERATING, DENTAL
• Manufacturer (Section D): ENGLE DENTAL SYSTEMS, LLC ; hillsboro OR 97124
• MDR Report Key: 9834827
• MDR Text Key: 183894616
• Report Number: MW5093757
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P024617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1