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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the harmony lc surgical light and was unable to find any evidence of the oil-like substance.The technician found the surgical light to be operating according to specification however, he noticed the plastic covers were missing on the joints of the lighting system.While onsite the technician ordered new plastic covers for the harmony surgical light for the biomed department to replace.The root cause of the reported event can most likely be attributed to residual cleaning solution as there is no oil or other fluid utilized in the manufacturing of the harmony lc surgical light.The harmony lc surgical light operator manual (pg 31) states: "4.2 general cleaning/disinfecting procedure: thoroughly wipe the areas to be cleaned.Rinse all surfaces with a clean soft cloth wipe and clear water.Wipe all surfaces dry with a clean dry soft cloth." the harmony lc surgical light was installed in (b)(6) 2008 making the unit approximately 10 years old and is not under steris contract agreement for preventive maintenance activities.The facilities biomed department is responsible for all maintenance activities.The technician counseled the facility's biomed department on the proper use and maintenance of the harmony lc surgical light specifically, proper cleaning techniques.No additional issues have been reported.

Event Description

The user facility reported an oil-like substance dripped from their harmony lc surgical light onto the surgical table during a patient procedure.No report of injury, procedure delays or cancellations.The procedure was completed successfully.

• Brand Name: HARMONY LC 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: 8232653
• MDR Text Key: 132573343
• Report Number: 1043572-2019-00006
• Device Sequence Number: 1
• Product Code: FTD
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• 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
• Date Manufacturer Received: 12/14/2018
• 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