MAUDE Adverse Event Report: MEDICAL ILLUMINATION INTRNATION INC. CENTURION LIGHT; SURGICAL LIGHT

Model Number 021515

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

The field failure od a 21st century centurion dual light system (model: 021515 / s/n: (b)(4)) arm was received into engineering for failure analysis.The customer states that the unit has been installed in an examination room and had normal usage over the past two decades with no insadents.The failed component was identified as the arm support fitting, (b)(4) a component of the spring arm where the extension arm assembly attaches to the spring arm.The spring arm assembly was dissassembled and all components were visually examined.Other than the arm support fitting (b)(4), no anomalies were found.The entire arm support fittting was visually inspected under 30x magnification and then cut into sections at highest "load" points on the unit to inspect for porosity.The analysis indicated the following.The unit was visually inspected, the material was consistent in color with virgin raw aluminum.The failure was identified at a point that contained a void in the material.The void appears to have been formed by the partial solidification of molten aluminum during the casting process.The break area appears to have several mico-craks radiating outwards from the fulcrum hole.This has been seen before in destruction tests when the center-bolt was overtighten.However, the cut-sections were inconclusive in that it could not be determined the actual depth of those cracks.We attribute that the failure was the direct cause of the void found in the broken arm support fitting component.This fauit could not have been identified in the incoming inspection or by the assembler.In speaking with the supplier of the componenet, he agreed that the void was likely caused by the partial solidification of the material saying that this was consistent with a pause in the pouring processes.

Event Description

On december 30th, it was reported to medical illumenation that a centurion light had a broken arm support fiting and was being sent in for repair.No injuries occured.

• Brand Name: CENTURION LIGHT
• Type of Device: 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: 11211032
• MDR Text Key: 229104596
• Report Number: 2028295-2021-00002
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 021515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1