MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR G-SERIES SURGICAL LIGHTING SYSTEM

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure a plastic screw fell from the harmonyair surgical lighting system g-series light head and contacted an employee on the shoulder.The user facility proceeded with the procedure which was completed successfully.No report of injury or procedure delay.

Manufacturer Narrative

The lighting system was installed in 2019 making it approximately 5 years old and is not under steris service agreement; the user facility is responsible for all maintenance activities.A steris service technician arrived onsite to inspect the lighting system; however, the user facility declined this offer.Per discussion with the user facility, it was determined that the screw detached from a non-steris light head adapter that was installed on the steris lighting system.Following the event, the screw was reinstalled by user facility personnel and the unit was returned to service.The harmonyair g-series surgical lighting system states (9), "warning personal injury hazard and/or equipment damage hazard accessories or replacement parts not listed in the operator manual or maintenance manual should not be used as it may affect emc or result in equipment damage.Repairs and adjustments to this equipment should be made only by fully qualified service personnel.Maintenance performed by inexperienced, unqualified personnel or installation of unauthorized parts could cause personal injury, invalidate the warranty, or result in costly equipment damage.Contact steris service regarding service options." the technician counseled user facility personnel on the proper use and maintenance of their lighting system, specifically using steris authorized parts.Steris will notify the manufacturer of the non-steris light head adapter, cardinal health, of the reported event to internally investigate and evaluate for reportability.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Manufacturer Narrative

Steris quality notified the manufacturer of the light head adapter, cardinal health, of the reported event to internally investigate and evaluate for reportability in accordance with 21 cfr part 803.No additional issues have been reported.

• Brand Name: HARMONYAIR G-SERIES 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: 18636528
• MDR Text Key: 334525586
• Report Number: 1043572-2024-00011
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00724995192051
• UDI-Public: 00724995192051
• 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: 02/02/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• 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