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

Model Number 061515-V

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

The product from customer complaint # (b)(4) was received and an investigation was initiated.A visual inspection showed that the arm support fitting (p/n 1002036) failed with no other apparent damage.We performed a structural analysis iaw failure analysis of the mi-1000 dated 07/16/2015.We reviewed the porosity of the material and found nothing irregular.The product was rebuilt so we could perform capacity testing.The unit passed a 6x load test for 24+ hours.We were unable to determine the reason for the failure.The potential for misuse is always present but we were unable to definitively tie this failure to any abuse or misuse.This brakeage is unusual as this was the only reported brakeage of this type of the (b)(4) arms shipped in 2015.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 fractured causing the light to fall.No injuries reported.

• Brand Name: MI-1000
• Type of Device: MINOR SURGICAL LIGHT
• Manufacturer (Section D): MEDICAL ILLUMINATION INTERNATIONAL 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: 8609538
• MDR Text Key: 145769101
• Report Number: 2028295-2018-00001
• 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
• Type of Report: Initial
• Report Date: 01/23/2018

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: Health Professional
• Device Model Number: 061515-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2015
• 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