On (b)(6) 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 50/100.As it was stated the cover was broken, label was torn and rust occured on the device.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.
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Getinge became aware of an issue with one of the surgical lights ¿ lucea 50/100.As it was stated, the cover was broken, the label was torn and rust occurred on the device.There was no injury reported, however, we decided to report the issue in an abundance of caution as any particles falling off into a sterile field or during a procedure may cause contamination.Based on the information collected, it was established that when the event occurred, surgical light did not meet its specification, since cracks in the cover, resulting in missing plastic particles, torn label and rust occurrence could be considered as a technical deficiency, and in these ways the device contributed to the event.There is no information if the device was or was not being used for a patient¿s treatment upon the event occurrence.When reviewing reportable events for these types of issues we were able to establish that the failure ratio of issues related to detachment of cover or its particles is low, the failure ratio of the rust occurrence is very low and the failure ratio for the torn label is very low.We have been able to confirm that the investigated issues have never led to serious injury or worse, to our knowledge.The analysis related to the issue of the cracked cover has been performed by the subject matter expert, and states that all maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety ad essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Disinfection products test: maquet sas describe how to perform the material resistance test in the working instruction ref.Fl 007.To avoid degradation of the shell it is recommended to respect the contact time and to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning.In 2015 a design change improved the braking system and the mechanical durability of the upper cover.The user manual (01741 rev.10, pages 26-27) mentions also to perform daily inspection in order to check the presence of paint chip, impact marks or other damage.To prevent a similar incident, it is recommended to respect the cleaning instructions avoiding: prolonged exposure to detergents and disinfectants solutions high concentrations prohibited products the new spare part is available ref: (b)(4) in order to repair the damaged product.Regarding the torn label issue, the subject matter expert established that the peeling of the label is probably due to repeated excessive rubbing during the cleaning of the device, and the use of aggressive or unsuitable cleaning agents may be a contributing factor.The rust problem was analyzed by the subject matter expert and concluded that the concentration of chemical products and the stagnation of cleaning agent residues on the disinfected surfaces are the main factors leading to the deterioration of surfaces.To avoid paint degradation and corrosion it is recommended to respect the cleaning instructions (user manual 01741 rev.10, pages 46-47) avoiding spraying, high concentrations, prolonged exposure to detergents/disinfectants solutions, to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning.To prevent any incident the user manual (01741 rev.10, pages 26-27) mentions to perform daily inspections in order to detect paint defects, impact marks or other damages.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendations had been followed the incident would have been avoided.Getinge 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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