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

Model Number	061525
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Custmer complaint #(b)(4) was issued for an mi-1000 light system (model: 061525 / s/n: (b)(6).Based on a few pictures provided to us, it appears that all 3 counter sink screws that secure the down tub to the ceiling mount had sheared off causing the light system to fail.We were unable to retrieve any sample material for evaluation.We cannot definitively dertermine a root cause of this issue.The force needed to shear one 8-32 screw is roughly 854lbs in single shear, since there are 3 screws and with a fos of 5 we are still seeing 500lbs to fail.If we acquire any addtional information on this issue, we will amend this report as necessary.
Event or Problem Description
On november 30th, it was reported to medical illumination that an mi-1000 light system had separated from the down tub to the ceiling mount.The reporter also stated someone had received stitches.We were unable to confim this due to location (seoul, korea).

• Brand Name: MI-1000
• Common Device Name: SURGICAL LIGHT
• Manufacturer (Section D): MEDICAL ILLUMINATION INTRNATION INC.; 19749 dearborn street; chatsworth CA 91311
• Manufacturer (Section G): MEDICAL ILLUMINATION INTRNATION INC.; 19749 dearborn street; chatsworth CA 91311
• Manufacturer Contact: robert hess ; 19749 dearborn street; chatsworth, CA 91311 ; 8188383025
• MDR Report Key: 18439766
• Report Number: 2028295-2023-00002
• Device Sequence Number: 7092654
• Product Code: FST
• UDI-Device Identifier: 00816835020171
• UDI-Public: 00816835020171
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K100388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 061525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown