MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR NG SILICONE STERILIZABLE COVER

Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported the silicone sterilizable cover to their harmonyair a-series lighting system detached during patient procedures and fell into the sterile field.A procedure delay was reported.No report of injury.
Additional Manufacturer Narrative
The silicone sterilizable cover subject of the reported event is being returned for evaluation.Investigation of this event is currently in process.A follow up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The sterilizable light cover subject of the reported event was returned to the supplier for evaluation.The light cover was tested and reviewed, and no abnormalities were identified.All specifications were met.Based on the evaluation, the likely cause of the reported event was that user facility personnel did not fully insert the light cover onto the light handle.User facility personnel were reminded of the importance of following the instructions for use when using the light cover.The packaging was not included with the return and the lot number is not printed on the cover, therefore, the lot number could not be determined.No additional issues have been reported.

• Brand Name: HARMONYAIR NG SILICONE STERILIZABLE COVER
• Common Device Name: STERILIZABLE COVER
• 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: 19131575
• Report Number: 1043572-2024-00022
• Device Sequence Number: 6900554
• Product Code: MDM
• UDI-Device Identifier: 00724995217358
• UDI-Public: 00724995217358
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown