MAUDE Adverse Event Report: STERIS SAS HEXALUX EXAMINATION LIGHT

Model Number HEXALUX CEILING MOUNT

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/19/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the lighting system and confirmed that the light head and spring arm had detached from the ceiling mount.The technician found that one of the threaded pins was not fully inserted in the spindle resulting in the reported event.The technician is awaiting parts to make the necessary repairs.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that their hexalux examination light came down from the ceiling contacting an employee's back.The unit did not completely detach from the ceiling as the electrical cable was still intact.No report of injury or procedure delay.

Manufacturer Narrative

The technician repaired the lighting system, tested the function and operation, and confirmed the lighting system to be operating according to specification.The technician performed an inspection of all the user facility's hexalux lighting systems and found them to be properly installed.No additional issues have been reported.

• Brand Name: HEXALUX EXAMINATION LIGHT
• Type of Device: EXAMINATION LIGHT
• Manufacturer (Section D): STERIS SAS; 116 avenue de magudas; le haillan, bordeaux 33185 ; FR 33185
• Manufacturer (Section G): STERIS SAS; 116 avenue de magudas; le haillan, bordeaux 33185 ; FR 33185
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 17152626
• MDR Text Key: 318029496
• Report Number: 3011221111-2023-00001
• Device Sequence Number: 1
• Product Code: KZF
• UDI-Device Identifier: 00724995167806
• UDI-Public: 00724995167806
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEXALUX CEILING MOUNT
• Device Catalogue Number: EXLCEIL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2019
• 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