MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY AIR G5 SURGICAL LIGHT

Device Problem Unintended Movement (3026)

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

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

The user facility stated the light was held up by user facility personnel and the procedure was completed successfully.A steris service technician arrived on-site, inspected the light, and confirmed it to be operating properly.No drifting of the lighting system spring arms was observed, the technician was unable to re-create the reported event.As a precaution, the technician adjusted the spring tension of the light and the unit was returned to service at the facility.No additional issues have been reported.

Event Description

The user facility stated their harmony air g5 surgical light drifted during a patient procedure tapping the surgeon performing the procedure.No procedure delay or cancellation was reported.Neither the surgeon or patient were injured due to the event.

• Brand Name: HARMONY AIR G5 SURGICAL LIGHT
• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7289586
• MDR Text Key: 100793332
• Report Number: 1043572-2018-00017
• 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: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• 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