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

Model Number 021515

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

The arm support fitting specified in customer complaint (b)(4) was received in to engineering for failure analysis.The component is on a dual centurion - ceiling mount model (021515 / s/n (b)(4)).The component was visually inspected and found to have failed on the 1002036 upper tang.The wear-and-tear of the unit was deemed very high because of its age and there were also indications that the component could have exceeded its load limits.We reviewed the manufacturing date of this unit and found on similar instances of this type of failure from this date code.We did multiple cross-section cuts and can rule out porosity as a possible cause of failure.However there appeared to be stress-related factors at the breaking point.These included a slight stretching of the aluminum tang which indicates that either the arm was overly stressed by weight or the torque on the component mounting bolt.Both conditions would give the same indication at the breaking point of the 1002036.We are attributing the ultimate cause of this failure of the 1002036 as being overstressed.We speculate that this light either had an excessive load applied on the arm or that the mounting bolt was over-tighten to remove drift in the system.This is derived from the fact that the tang had signs of slight stretching at the break line which is indicative of a stress failure or an over clenched bolt.

Event Description

On october 7th, an incident was reported to medical illumination about a broken arm support fitting on a centurion light system.There were no injuries.

• 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: 9271780
• MDR Text Key: 196117223
• Report Number: 2028295-2019-00003
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 021515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2005
• 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