MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY VLED SURGICAL LIGHTING SYSTEM

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure, the plastic cover from the suspension spring arm to their harmony vled surgical lighting system fell into the sterile field.The patient procedure was completed successfully following a delay.No report of injury.

Manufacturer Narrative

A steris service technician inspected the harmony vled surgical lighting system and found that the two halves of the plastic cover where the lighthead mounts on the suspension spring arm were broken and detached.The technician stated that the screws installed to secure the cover halves were intact along with portions of the covers still secure under those screws.The technician's inspection and evaluation indicates the cover halves were damaged in a manner to compromise their physical integrity.The damage observed to the plastic covers on the suspension spring arm are indicative of force (such as impact) that the suspension arm sustained from other objects.The harmony vled surgical lighting system operator manual states, "caution - possible equipment damage: - do not bump lightheads into walls and other equipment." the steris account manager offered in-service training on the proper use and operation of the harmony vled surgical lighting system and the importance of not bumping the lightheads into walls or equipment however, the user facility declined.The steris service technician replaced the covers on the suspension spring arm, tested the function and operation of the harmony vled surgical lighting system, confirmed it to be operating properly and returned it to service.No additional issues have been reported.

• Brand Name: HARMONY VLED SURGICAL LIGHTING SYSTEM
• Type of Device: SURGICAL LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19140556
• MDR Text Key: 340921732
• Report Number: 1043572-2024-00023
• Device Sequence Number: 1
• Product Code: FSY
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2011
• 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