On 26th july, 2021 getinge became aware of an issue with one of our surgical lights ¿ blue 80-30.The cover and screws were missing.The headlight's cover was melted, what resulted in missing particles.No injury was reported due to mentioned issues, however, we decided to report this case in abundance of caution as any parts or particles falling down might cause contamination or led to serious injury.
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Getinge became aware of an issue with one of our surgical lights ¿ blue 80-30.The cover and screws were missing.The headlight's cover was melted, what resulted in missing particles.No injury was reported due to mentioned issues, however, we decided to report this case in abundance of caution as any parts or particles falling down might cause contamination or led to serious injury.It was established that when the event occurred, the device did not meet its specification, due to cover and screw were missing on the device and it contributed to event.It was not established if in the time when the event occurred the device was or was not being used for the patient treatment.During the investigation, it was found that the reported scenario has never led, to date, to serious injury or worse.Manufacturer did not receive enough information to conduct the technical investigation.It is not possible to determine the part involved and the root cause.In case of new relevant information, the case will be reconsidered.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.
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