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

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/26/2023

Event Type  malfunction  

Manufacturer Narrative

A steris surgical service representative inspected the lighting system and reported the indicated yoke cover was damaged as the mounting screws and parts of the yoke cover were still attached to the lighting system.The observed damage is indicative of impact damage caused by user facility personnel bumping the light head into walls or other equipment.The harmony led surgical lighting operator manual is included with every steris harmony led surgical lighting system sold.The following cautionary statement is documented within the safety precautions section of this manual.The instructions further state (1-3), "caution - possible equipment damage hazard: do not bump light heads into walls or other equipment.Always use handles when positioning light head during surgical procedures, or when cleaning or servicing the lighting system." a steris account manager contacted the customer to inquire an in-service training presentation on the use of their harmony led surgical lighting system, specifically not bumping the lighting system into walls or other equipment, however the customer declined.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure, the plastic lighthead yoke cover on the harmony led surgical lighting system detached and fell from above, causing the cover to contact a surgeon on the head and shoulder.No report of injury.The procedure was completed successfully.

• Brand Name: HARMONY LED SURGICAL LIGHTING SYSTEM
• Type of Device: 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: 18581544
• MDR Text Key: 333744087
• Report Number: 1043572-2024-00008
• 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: 01/25/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2009
• 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