On (b)(6) 2021 getinge became aware of an issue with one of our surgical light - powerled.As it was stated during inspection of the device technician noticed that handle of the device had been broken off.No information about any injury was provided, however we decided to report this case in abundance of caution as considering the worst case scenario which is unexpected handle detachment and falling off into sterile field or during procedure, the issue may cause contamination.
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Getinge became aware of an issue with one of our surgical light - powerled.As it was stated during inspection of the device technician noticed that handle of the device had been broken off.No information about any injury was provided, however we decided to report this case in abundance of caution as considering the worst case scenario which is unexpected handle detachment and falling off into sterile field or during procedure, the issue may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification as the handle shouldn¿t detach and it contributed to incident in that way.There is no information if at the time when the event occurred the device was or was not being used for patient treatment.The results of the torque and tensile tests (report re10-127) shows that the handle can withstand a load of 100 n and comply with the iec standard 60601-2-41 ed 2.The separation of the devon handle was caused by a deterioration of the fixing holes, tearing the threads, due to excessive loads (> 100 n) applied on the handle.To prevent any incident the powerled user manual 01581en09 page 20 mentions : ¿check the light heads for chipped paint, impact marks and any other damages¿.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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