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 02/19/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician inspected the surgical light and confirmed that half of the yoke cover had detached.The technician replaced the yoke cover and confirmed the light to be operating properly.No additional issues have been reported.The technician stated that the reported event may be attributed to impact damage.The operator manual states (pp.1-3), "do not bump lightheads into walls or other equipment." the operator manual further 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.".

Event Description

The user facility reported that during a patient procedure half of the yoke cover from their surgical light fell off.The yoke cover did not enter the sterile field; the patient procedure was completed successfully.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: 5492585
• MDR Text Key: 40334853
• Report Number: 1043572-2016-00022
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• 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: 02/19/2016
• 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