On 1st february, 2021 getinge became aware of the issue with hled surgical light.As it was stated, the locking ring and push button fell off the device.There was no patient involvement.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.The surgical light involved in the event is hled 700 df hd r k4 ql, with catalog number ard568371958 and serial number (b)(6).The manufacturing date is 7th march, 2017.It was established that when the event occurred, the surgical light did not meet its specification since there was a failure of the sterilizable handle holder mechanism, leading to the detachment of its parts.The device which played role in this situation contributed to the event.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment.In the course of our investigation, the most likely root cause of the circlip¿s breakage is considered to be an oxidation due to not resistant enough material used.The curative and preventive action plan has been initiated to identify the reason of this oxidation.Then, it has been decided to improve the current circlip material stainless steel a2 by stainless steel a4 more resistant to chemicals.The salt spray tests made in laboratory prove that circlips made in stainless steel a4 solve the oxidation troubles.According to this result, the modification has been applied in our production line since 9th november 2017.We believe that the 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.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.Remedial action msa-2019-002-iu was raised to address the problem.
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