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

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 09/15/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived onsite and found that the yoke cover had been replaced by the user facility's third party service provider.The surgical light was found to be operating properly and returned to service.No additional issues have been reported.The reported event may be attributed to bumping of the surgical light heads into other equipment.The operator manual states (pp.1-4), "do not bump lightheads into walls or other equipment.Always use handles when positioning lighthead during surgical procedures, or when cleaning or servicing the lighting system." the surgical light is not under steris service contract and is serviced and maintained by the user facility's third party service provider.

Event Description

The user facility reported that the yoke cover from their surgical light detached and fell into the sterile field during a patient procedure.No report of injury or procedural delays or cancellations.

• Brand Name: HARMONY LED 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5574274
• MDR Text Key: 43175315
• Report Number: 1043572-2016-00038
• 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: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• 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: 03/31/2016
• 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