On 24th june, 2022 getinge became aware of an issue with one of our surgical lights ¿ hanaulux 3004.As it was stated, headlight's seal was damaged with missing particles, corrosion has built up on the device and the paint was peeling.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 our surgical lights ¿ hanaulux 3004.As it was stated, headlight's seal was damaged with missing particles, corrosion has built up on the device and the paint was peeling.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.Based on the information collected, it was established that when the event occurred, the surgical lightdid not meet its specification due to headlight's seal damage with missing particles, corrosion and paint peeling, which could be considered as technical deficiencies, and in this way the device contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.The deterioration of the light head seals is probably due to infiltration and stagnation of aggressive cleaning products caused by inappropriate cleaning.However, the cleaning protocol was not provided.To prevent any incident, the hlx3000 user manual mentions instructions concerning cleaning and disinfection, recommended and prohibited products.To avoid paint degradation and corrosion it is recommended to respect the cleaning instructions avoiding 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.The hlx3000 user manual mentions to check the lightheads for chipped paint, impact marks and any other damages during daily checks.(hlx 3000 user manual en 0132102 2g, pages 19-23) we believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have 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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