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

Model Number E-Series

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

The user facility reported that one of the lightheads detached from the spring arm of their harmonyair e-series surgical lighting system.No report of injury or procedure delay.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the lighting system and found that the snap ring had become dislodged from where installed and the stop pin was broken.Due to the damage, the technician made the necessary repairs, tested the lighting system, confirmed it to be operating according to specification, and returned it to service.The observed damage to the pin is indicative of the lighthead being subject to a high load of impact by user facility personnel.The technician counseled the user facility on the proper use and operation of the harmonyair e-series surgical lighting system.No additional issues have been reported.

• Brand Name: HARMONYAIR E-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: 13895676
• MDR Text Key: 296307373
• Report Number: 1043572-2022-00021
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00724995172749
• UDI-Public: 00724995172749
• 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: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E-Series
• Device Catalogue Number: LEH02INNDT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2019
• 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