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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 05/16/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility stated the employee sought medical treatment at the facility's er but was unable to determine why the employee was sent to the er.The user facility initially reported to customer service that the monitor arm was drifting thus causing the employee to hit their head.A different user facility employee stated to the steris service technician that the monitor arm was not drifting.A steris service technician inspected the lighting system and found it to be operating properly.No drifting of the surgical monitor arm was observed and the lighting system was confirmed to be operating to specifications.The lighting system was returned to service and no additional issues have been reported.

Event Description

The user facility reported that an employee was moving around the operating room and turned their head hitting it on the lower corner of the monitor.

• Brand Name: HARMONYAIR SURGICAL LIGHTING SYSTEM M SERIES
• 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5729597
• MDR Text Key: 47549856
• Report Number: 1043572-2016-00053
• 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: 06/16/2016

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: 05/17/2016
• Initial Date FDA Received: 06/16/2016
• 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