On (b)(6) 2021 getinge became aware of an issue with lucea 100 surgical light.The cover was cracked and particles were missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into steriel field or during procedure may cause contamination.
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Getinge became aware of an issue with lucea 100 surgical light.The cover was cracked and particles were missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Conclusions from performed investigation indicates the most probable root cause of the cracks is a combination of different factors: mechanical stress, use of inappropriate cleaning/disinfections products, or inappropriate cleaning and disinfection protocols.The equipment was repaired.New parts were applied and device was back to usage.If the described failure occurs, the user can visually detect it during the daily checks to be performed prior to each use, or during preventive maintenance.In this case, the user would contact a getinge representative to replace the defective covers of the affected device.For cleaning, the ifu informs the user to not use aggressive and abrasive products.During disinfection, it is prohibited to spray the disinfectant solution directly on the device and use inappropriate disinfectants.To prevent any incident the lucea50-100 user manual (nu_lucea_50_100_01741en) mentions: ¿check the light heads for chipped paint, impact marks and any other damages¿ during daily inspections.We believe that overall the devices on the market are performing correctly.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.
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