On 14th march, 2022 getinge became aware of an issue with one of our surgical lights ¿ powerled.As it was stated, the stop pin was damaged.Such issue can lead to grinding during movement, creating risk of detachment of filings.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 one of our surgical lights ¿ powerled.As it was stated, the stop pin was damaged.Such issue can lead to grinding during movement, creating risk of detachment of filings.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 due to broken rotation stop on the headlight, which contributed to the event.Provided information indicate 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.Comparing the number of claimed devices to number of sold devices worldwide, we can assume that the failure ratio of broken rotation stop pin on the headlight occurrence is low.According to the subject matter expert at the manufacturer¿s, the problem with the stops rotation reported on some pwd700 and hled 700 light heads is due to a lack of contact area between the stops.These stops realized with screw heads seem to be too short and become ineffective over time.The result is that the light can rotate freely, unplugging the cables and eventually creating some metal fillings.In september 2011, maquet sas has changed these screws in the production line but has not noticed any adverse outcome.Before this date, the screws were a bit longer, hence the stops stronger and should not be concerned by this problem.This issue is followed through the capa#464134.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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