MAUDE Adverse Event Report: MEDICAL ILLUMINATION INTRNATION INC. MI-15 (CENTURION EXCEL) SUGICAL LIGHT CENTURY CENTURION

Model Number 021514

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

The arm assembly from customer complaint (#(b)(4)) was received and identified as a sigle 21st century centurion light system (model 021514, s/n: (b)(4)). The unit was hung and visually inspected as a system. After we made out initial visual observations, we performed an in-depth analysis on the failure. The arm support fitting ((b)(4)) was identified as the failed component. We inspected the component at the break and found no evidence of porosity or irregular material flow in the area. In our analysis we observed surface damage consisting of deep circular gouges in the area under the nut attached to the coupling bolt. This would be indicative of an overtightened condition which would stress the casted aluminum tangs to a point of failure. We have witnessed this before when a customer attempted to increase the friction level of the suspension arm to minimize horizontal drift. However, we could not definitely prove this theory in that we only observed the visual incongruity while the stress fractures in the component were not readily apparent. Note: this report is late because it was sent to the test emdr instead of production.

Event Description

On may 17th an incident was reported to medical illumination regarding century centurion light system arm that had broken and grazed the doctors shoulder. We contacted the facility and spoke with the doctor to see if any injuries occured. He stated, no injuries to report.

• Brand Name: MI-15 (CENTURION EXCEL) SUGICAL LIGHT
• Type of Device: CENTURY CENTURION
• Manufacturer (Section D): MEDICAL ILLUMINATION INTRNATION INC.; 547 library street; san fernando CA 91340
• Manufacturer (Section G): MEDICAL ILLUMINATION INTRNATION INC.; 547 library street; san fernando CA 91340
• Manufacturer Contact: robert hess ; 547 library street; san fernando, CA 91340 ; 8188383025
• MDR Report Key: 8614072
• MDR Text Key: 145946867
• Report Number: 2028295-2018-00006
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 021514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse