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

Model Number 061515

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

The lighting system was installed in a vertinarians examination room with normal use and no extreme instances reported.The arm support fitting component (p/n 1002036) was not available to the engineering group to perform a root cause analysis so the following assumptions of the failure are derived only from the pictures supplied from the customer.The pictures show several things pertinent to the failure.The material appears to be solid and null of any voids indication that there was no porosity or material breakdown.The material appears to be consistent in color with virgin raw aluminum material - no contamination observed.The break appears to be consistent and straight indicating that this likely happened instantaneously and not over a period of time.The breaking point is located at the through hole on the arm pivot point.This could also be consistent with a sudden impact of the arm assembly to a solid or hard object but this speculation cannot be fully substantiated from a photograph.In researching this failure we found two (2) other reported field failures with similar visual indications.One of the failures was a result of a hard impact against a wall and the other failure occurred when a medical technician admittedly over-tightening the pivot screw.Both incidents were deemed operator caused.It is impossible to definitively assign cause to this analysis because we do not have the physical component that failed.It is also speculation that this component operated normally within specified range of normal operation.Note: this report is late because it was sent to the test emdr instead of production.This issue has been resolved.

Event Description

On (b)(6) 2019 it was reported to medical illumination that a mi-1000 had a broken arm support fiting p/n 1002036 and was sent in to be repaired.No injuries occured.

• 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: 8614077
• MDR Text Key: 145946718
• Report Number: 2028295-2019-00001
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was 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: Other
• Device Model Number: 061515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1