MAUDE Adverse Event Report: STERIS SAS HEXALUX EXAMINATION LIGHT

Device Problem Installation-Related Problem (2965)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

The user facility reported that the spring arm on their hexalux examination light detached at the end of a patient procedure.No report of injury or procedure delay.

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the lighting system and found that the examination light was improperly installed.As a result of improper installation, the retaining ring became loose causing the spring arm to detach.The subcontractor responsible for installation was retrained on the proper installation procedure.The technician reinstalled the lighting system, tested it, confirmed it to be operating according to specification, and returned it to service.As a precautionary measure, the technician inspected all the other hexalux lighting systems at the user facility to confirm proper installation and operation.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: 18067708
• MDR Text Key: 327316427
• Report Number: 3011221111-2023-00003
• 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
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• 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