On 25th december, 2020 getinge became aware of an issue with one of surgical lights.As it was stated by the customer, the oil leakage on the spring arm was noticed.There was no injury reported however we decided to report the issue and based on the potential as any oil droplets falling off into sterile field or during procedure may lead to contamination.
|
Getinge became aware of an issue with one of surgical lights - hanaulux.As it was stated by the customer, some droplets of oily substance leakage on the spring arm appears to have been noticed.There was no injury reported however, we decided to report the issue and based on the potential as any unsterile droplets falling off into sterile field or during procedure may lead to contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.There is no information if upon the event occurrence, the device was or was not being used for patient treatment.During the investigation, it was found that in the past the reported scenario has never lead to serious injury or worse, to death.Unfortunately, manufacturer did not receive enough information to conduct the technical investigation.It is not possible to determine the root cause and therefore the factory investigation report cannot be performed.In case of new relevant information, the case will be reconsidered.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.
|