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

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the harmonyair e-series surgical lighting system and found that the screw insert for the cover was damaged allowing the cover to detach and the reported event to occur.Additionally, the technician observed that the tabs that attach the cover to the spindle were broken.Based on the technician's inspection the reported event is attributed to the cover not being properly aligned with the vertical tube causing damage to the cover over time.The harmonyair e-series surgical lighting system is not under steris service agreement.The user facility is responsible for all maintenance activities the technician replaced the cover, tested it, confirmed it was operating according to specification, and returned it to service.A 2-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that during patient positioning one of their harmonyair e-series surgical lighting system cover halves detached and fell, contacting the surgeon's hand.The surgeon replaced the glove that was contacted, and the procedure was completed successfully.No report of injury.

• Brand Name: HARMONYAIR E-SERIES SURGICAL LIGHTING SSYSTEM
• 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: 12143602
• MDR Text Key: 263098648
• Report Number: 1043572-2021-00050
• 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: 07/09/2021

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: 06/10/2021
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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