MAUDE Adverse Event Report: STERIS SAS HEXALUX EXAMINATION LIGHT

Device Problems Detachment of Device or Device Component (2907); Installation-Related Problem (2965)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in process, a follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that the light spring arm to their hexalux examination light detached.The patient was not present in the room during the time of the event.No report of injury.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the lighting system and found that one of the components that helps support the lighting system and keep the retaining ring in place was not installed properly.The retaining ring then loosened which caused the reported event.An investigation revealed that the original installation technician did not properly install the light; this employee was retrained on the proper installation technique.The service technician replaced the light, tested it, confirmed it to be operating according to specification, and returned it to service.The technician inspected all other lighting systems at the user facility.All were confirmed 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: 18436741
• MDR Text Key: 331809558
• Report Number: 3011221111-2024-00001
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2023
• 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