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

Device Problems Contamination of Device Ingredient or Reagent (2901); Detachment of Device or Device Component (2907)

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

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

The plastic cover did not contact the patient or surgical staff.No injuries were associated with the reported event.A steris service technician arrived onsite to inspect the surgical lighting system and found that both screws that secure the cover to the light were still in place; however, the yoke cover appeared to be damaged.The technician installed a replacement cover for the subject surgical lighting system, confirmed the lighting system was operating properly, and returned the unit to service.Based on the description of the reported event, it appears the surgical lighting system sustained impact damage resulting in the detachment of the yoke cover.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." a steris account manager counseled user facility personnel of the proper use and operation of the led surgical lighting system.The lighting system was installed in 2015 and is under steris service agreement.No additional issues have been reported.

Event Description

The user facility reported that one of the plastic yoke covers on their harmony led surgical lighting system fell into the sterile field during a patient procedure.A procedure delay was reported as the sterile field was re-established, and the procedure was completed successfully.

• Brand Name: HARMONY LED SURGICAL LIGHTING SYSTEM
• Type of Device: 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: 7786575
• MDR Text Key: 117433460
• Report Number: 1043572-2018-00065
• 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: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• 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: 07/20/2018
• 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