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

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

A steris surgical service technician inspected the lighting system and reported the indicated yoke cover was damaged as the mounting screws and parts of the yoke cover were still attached to the lighting system.The observed damage is indicative of impact damage caused by user facility personnel bumping the lighthead into walls or other equipment.The steris technician replaced the lighthead cover and confirmed unit was operational.Lighting system was returned to service.The harmonyair m-series surgical lighting system operator manual states, "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.".A steris account manager to offer counseling on the proper use and operation of the lighting system.A follow-up mdr will be submitted should additional information become available.No additional issues have been reported.

Event Description

The user facility reported the surgical lighthead cover to a harmonyair m-series surgical lighting system fell off during procedure.There was a procedure delay as the facility personnel had to reestablish the sterile field.Procedure was completed and no report of injury.

• 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
• MDR Report Key: 19055278
• MDR Text Key: 339687370
• Report Number: 1043572-2024-00019
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00724995191566
• UDI-Public: 00724995191566
• 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: 04/05/2024

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: 03/07/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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