MAUDE Adverse Event Report: MEDICAL ILLUMINATION INTRNATION INC. MI-1000 DUAL CEILING; MINOR SURGICAL LIGHT

Model Number 061515-V

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

We received the returned light under customer complaint : (b)(4) and an investigation was initiated.The unit was visually inspected and the arm support fitting (p/n 1002036) was found to have failed.No other damage was observed.Having see a similar failure within the past six months, we performed multiple cut cross-section analysis to rule out porosity as a cause of failure.The material porosity looked normal and no stress-related factors were found.The product could not be capacity tested due to the failure location so it was rebuilt and tested with a p/n 1002036.We then tested the system to the failure analysis of the mi-1000 system dated 07/16/2015.The unit passed all tests.We could not determine the ultimate cause of the failure of the p/n 1002036.The load test was performed at 6x and the unit showed on degradation.Note: this report is late because it was sent to the test emdr instead of production.

Event Description

On (b)(6) 2017 an incident was reported to medical illumination regarding an mi-1000 arm support fitting causing the light to fall.There were no injuries.

• Brand Name: MI-1000 DUAL CEILING
• Type of Device: MINOR SURGICAL LIGHT
• 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: 8609840
• MDR Text Key: 145538778
• Report Number: 2028295-2018-00003
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• PMA/PMN Number: K100388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 061515-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1