MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY AIR G-SERIES SURGICAL LIGHTING SYSTEM

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

A procedure delay occurred due to a compromise of the sterile field.The sterile field was re-established, and the procedure was completed successfully.A steris service technician arrived on site, inspected the lighting system, and identified that the canopy extender required adjustment.The canopy extender was properly positioned, secured and placed back to service.The technician identified several conditions at the user facility contributed to the gasket becoming dislodged.Specifically, cleaning practices completed by user facility personnel along with adjustments which were made to the height of the spring arms allowed for the compromise of the protective canopy extender and resulted in the rubber gasket falling during the reported event.The steris operator manual states on page 1-1 "warning - personal injury hazard and/or equipment damage hazard: repairs and adjustments to this equipment should be made only by fully qualified service personnel.Maintenance performed by inexperienced, unqualified personnel or installation of unauthorized parts could cause personal injury, invalidate the warranty or result in costly equipment damage.Contact steris service regarding service options." the user facility's steris account manager will provide in-service training on the proper use and operation of the harmony air g-series surgical light including the proper cleaning practices.

Event Description

The user facility reported the canopy extender of their harmony air g-series surgical lighting system became dislodged from the installed location causing a rubber gasket to fall during a patient procedure.No injury to patient or user facility staff was reported.

Manufacturer Narrative

Steris became aware of this event on 1/11/2017 and filed mdr 1043572-2017-00007 on 2/8/2017.Upon receipt of user facility medwatch mw5067475 on 2/20/2017 we reviewed our service history and confirmed the event described in medwatch mw5067475 is the same event which was reported in mdr 1043572-2017-00007.

Event Description

Reference medwatch mw5067475.

Manufacturer Narrative

A steris account manager completed in-service training with the user facility on the correct usage of the lighting system, including correct cleaning and disinfecting practices on (b)(4) 2017.

• Brand Name: HARMONY AIR G-SERIES SURGICAL LIGHTING SYSTEM
• Type of Device: SURGICAL LIGHT
• 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6310476
• MDR Text Key: 67215616
• Report Number: 1043572-2017-00007
• 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,Followup,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• 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
• Date Manufacturer Received: 01/11/2017
• 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