MAUDE Adverse Event Report: MEDICAL ILLUMINATION INTERNATIONAL, INC. CENTURION EXCEL ; MINOR SURGICAL LIGHT

Model Number 061514

Device Problems Break (1069); Off-Label Use (1494)

Patient Problem Injury (2348)

Event Date 06/12/2012

Event Type  malfunction  

Manufacturer Narrative

The light and arm were returned to the factory for analysis.Upon arrival, the arm support fitting was inspected for porosity and/or voids in the material.No anomalies in the material were found.The arm support material was also identified that it was the specified material.Additional testing of new product was performed to verify production parts performed as designed.Unable to determine exact cause of this failure.Will monitor for any future occurrences.The arm support component was put under test with a 6x load to confirm the initial load handling capacity.This test was confirmed as positive and the case was close with the replacement of the light on (b)(4) 2012.

Event Description

On (b)(6) 2012 an incident was reported to medical illumination regarding an excel light arm support fitting fractured causing the light to fall hitting the doctor on his back.The light fell when being removed.

• Brand Name: CENTURION EXCEL
• Type of Device: MINOR SURGICAL LIGHT
• Manufacturer (Section D): MEDICAL ILLUMINATION INTERNATIONAL, INC.; san fernando CA
• Manufacturer Contact: robert hess ; 547 library st.; san fernando, CA 91340 ; 8188383025
• MDR Report Key: 4943577
• MDR Text Key: 22692946
• Report Number: 2028295-2015-00001
• Device Sequence Number: 1
• Product Code: LBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 061514
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/12/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1