On 7th december, 2020 getinge became aware of an issue with powerled ii surgical light.As it was stated by the customer, particles from sterilizable handle holder were falling during maneuvering of the recently installed headlight.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 powerled ii surgical light.As it was stated by the customer, particles from sterilizable handle holder were falling during maneuvering of the recently installed headlight.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.It was established that when the event occurred, the surgical light did not meet its specification, since debris particles falling from sterilizable handle holder could be considered as technical deficiency, and in this way device contributed to event.The device was being used for patient treatment at the time when the event occurred.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue is isolated case and has never led to serious injury or worse, to our knowledge.The faulty sterilizable handle holders were replaced, what solved the issue.The reason of these little particles inside the quick lock handle holder system remains unknown.Actually, faulty parts were returned to the manufacturer, but it was not possible to reproduce the issue.On the other hand, if a pollution existed during the manufacturing or at the supplier, which is not the case in this complaint, at least a whole batch would have been contaminated and not only two devices.We believe the related devices are performing correctly in the market.Given the circumstances, we 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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