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

Model Number M-Series Surgical Lighting System

Device Problem Unintended Collision (1429)

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

Event Date 05/25/2022

Event Type  malfunction  

Event Description

The user facility reported that during a patient procedure the spindle cover was struck by a lighthead connected to the spindle assembly.A short time later, the spindle cover fell onto the patient.The procedure was completed successfully, and no injuries were reported.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the harmonyair surgical lighting system and confirmed that the spindle cover required replacement due to the impact from the lighthead during the reported event.No issues were noted with the function or operation of the lighting system.The technician replaced the spindle cover and confirmed the lighting system to be operating according to specification.The steris service technician counseled user facility personnel of the importance of not bumping equipment into each other as stated in the operator manual.The operator manual states (section 1), "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 operator manual further states (sec.5.6), "lighthead positioning - states: caution - possible equipment damage hazard: do not bump lightheads into walls or other equipment." no additional issues have been reported.

• Brand Name: HARMONYAIR M-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 ; 4403927453
• MDR Report Key: 14776468
• MDR Text Key: 294517360
• Report Number: 1043572-2022-00045
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00724995165932
• UDI-Public: 00724995165932
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-Series Surgical Lighting System
• Device Catalogue Number: LMH01N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• 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