Getinge became aware of an issue with powerled surgical light.The connection between the fork and the headlight was grinding during movement, creating risk of detachment of filings.There was no injury reported however we decided to report the issue based on the potential and 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 grinding could be considered as technical deficiency, and in this way device contributed to event.There is no information if the device was or was not 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 has never led to serious injury or worse, to our knowledge.The problem with the stops rotation 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.
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The correction of d4 catalog #, serial # and h4 manufacture date deems required, therefore we submit supplemental report.Previous d4 catalog # ard568371939.Corrected d4 catalog # ardpwd259001a.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).Previous h4 manufacture date 2018-05-03.Corrected h4 manufacture date 2018-01-18.Previous complaint summary: getinge became aware of an issue with powerled surgical light.The connection between the fork and the headlight was grinding during movement, creating risk of detachment of filings.There was no injury reported however we decided to report the issue based on the potential and 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 grinding could be considered as technical deficiency, and in this way device contributed to event.There is no information if the device was or was not 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 has never led to serious injury or worse, to our knowledge.The problem with the stops rotation 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 (b)(6) 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.Corrected complaint summary: getinge became aware of an issue with powerled surgical light.The connection between the fork and the headlight was grinding during movement, creating risk of detachment of filings.There was no injury reported however we decided to report the issue based on the potential and any particles falling off into sterile field or during procedure may cause contamination.According to the service technician, the device has been repaired.It was established that when the event occurred, the surgical light did not meet its specification, since grinding could be considered as technical deficiency, and in this way device contributed to event.There is no information if the device was or was not 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 has never led to serious injury or worse, to our knowledge.Taking into consideration install base and the number of the complained devices we could conclude that the complaint ratio is very low.The problem with the stops rotation 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 (b)(6) 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.
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