On (b)(6) 2022 getinge became aware of an issue with one of our examination lights ¿ lucea 40.According to photographic evidence, covers were damaged with missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off during examination may lead to potential infection of the patient.
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Getinge became aware of an issue with one of our examination lights ¿ lucea 40.According to photographic evidence, covers were damaged with missing particles.There was no injury reported, however, we decided to report the issue in an abundance of caution as any particles falling off during examination may lead to potential infection of the patient.According to the information provided by the service unit, the device has been repaired by the replacement of faulty parts.Based on the information collected, it was established that when the event occurred, the examination light did not meet its specification, since cracks in covers, resulting in missing plastic particles could be considered a technical deficiency, and in this way the device contributed to the event.The provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing reportable events for this type of issue we were able to establish that the received incidents are occurring at a moderate ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.According to the analysis performed by the subject matter expert, the cracks detected on the handle interface and transparent cover fixing points were probably caused by improper use, collisions, incompatible cleaning products or protocol.To prevent any incident the lucea10/40 ifu 01701 en 11 on page 21 mentions to check the integrity of the light heads during daily inspection.Furthermore, the same user manual on pages 28-29 explains how to clean and disinfect the light heads.This document includes some recommended products and some prohibited products.In order to avoid torques applied on the transparent housing during use the lucea10/40 ifu 01701 en 11 on page 24 mentions to handle the light head by the handle.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could 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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