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

Model Number 061514-V

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

We received the returned light listed under customer complaint #(b)(4) and imitated an investigation.The product was a mi-1000 single ceiling mount.A visual inspection was performed and other than the arm support fitting (p/n 1002036) there was light surface damage found (ie: nicks and scratches).Because the arm support fitting (1002036) was tested several weeks ago under rma # (b)(4) for another customer complaint (#(b)(4)).The load test was not run again.We did cross-section analysis on the failed surfaces and did not see any porosity or abnormal material flow patterns.We could not definitively determine the cause of the failure.The light surface damage was deemed inconsequential.This are was out of (b)(4) sold in 2014 and this is the only failure of this component reported for that production year.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 fracturing causing the light to fall.There were no injuries.

• Brand Name: MI-1000
• 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: 8609589
• MDR Text Key: 145768881
• Report Number: 2028295-2018-00002
• 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: company representative,distri
• Type of Report: Initial
• Report Date: 01/25/2018

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: Other
• Device Model Number: 061514-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1