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

Device Problem Break (1069)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the lighting system and found that the cover had been damaged with hairline cracks.The damage was observed where the screw is installed to attach the cover to the lighting system.Due to the damage, the cover detached from the lighting system resulting in the reported event.The technician has ordered the replacement cover required to repair the lighting system.Our investigation into the reported event is in process.A follow up report will be submitted when additional information becomes available.

Event Description

The user facility reported that the cover to their harmonyair a-series surgical lighting system fell off during a patient procedure.User facility personnel caught the cover preventing it from falling onto the patient or sterile field.The procedure was completed successfully, no report of injury.

Manufacturer Narrative

The steris service technician stated that the observed hairlines cracks where the screw is inserted may be attributed to over-tightening of the mounting screw or impact damage from another hard object.The harmonyair a-surgical lighting system states, "caution: possible equipment damage: do not bump lightheads into walls or other equipment.Always use handles or gripping surface when positioning lighthead during surgical procedures, or when cleaning or servicing the lighting system." the technician repaired the harmonyair a-surgical lighting system, tested the function and operation of the unit, and returned it to service.No additional issues have been reported.

• Brand Name: HARMONYAIR A-SERIES 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: 18291146
• MDR Text Key: 330252057
• Report Number: 1043572-2023-00166
• 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,Followup
• Report Date: 12/08/2023

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: 11/09/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• 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