Getinge became aware of an issue with one of examination lights - lucea 40.During preventive maintenance the cracked covers were discovered.It was confirmed by photographic evidence the headlight was cracked with possibility of missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause infection.It was established that when the event occurred, the surgical light did not meet its specification due to cracks and possibility of missing particles from cover, which contributed to the event.Provided information indicates that upon the event occurrence the device was not being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.We can assume that the failure ratio of cracks and missing particles on lucea 10/40 devices is moderate.A root cause analysis was performed by subject matter experts at manufacturing site.Based on some internal test done by maquet sas (ref: cre 12-085 for instance), only abnormal use (violent collisions, excessive pressure¿) or the use of incompatible cleaning products or protocol, can damage this device as reported in this complaint.Tests performed by getinge did not lead to cracks as reported in the complaint at hand.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 instruction for use ifu 01701 mentions to check the integrity of the light heads during daily inspection and describes how to clean and disinfect the light head.This document includes some recommended products and some prohibited products.In order to avoid mechanical stresses applied on the transparent housing during use the lucea10/40 instruction for use ifu 01701 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 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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