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

Device Problems Material Separation (1562); Device Fell (4014)

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

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the lighting system and confirmed that the screw had detached.The technician inspected all of the screws on the lighting system and confirmed they were properly attached.The technician reinstalled the screw, tested the lighting system, confirmed it to be operating according to specifications, 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 a patient procedure one of the screws to the spindle cover on their harmonyair e-series surgical lighting system detached and fell, entering the sterile field.The screw was removed and the sterile field was reestablished resulting in a procedure delay; the procedure was completed successfully.No report of injury.

• Brand Name: HARMONYAIR E-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 ; 4403927453
• MDR Report Key: 10977895
• MDR Text Key: 221284906
• Report Number: 1043572-2020-00061
• 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: 12/09/2020

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/09/2020
• 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