Investigation results: visual investigation: the lever was not on the coupling anymore upon receipt.Besides that, the device is in a used but good condition.The investigation has been carried-out by the aesculap technical service (ats).Normal signs of wear cold be found.Pressure and exhaust air tight according to specification.Lever is not on the coupling anymore.The next maintenance date would have been necessary in may 2021, complaint received: april 2021.Based on the provided information and after the investigation, a clear conclusion cannot be drawn.An internal change (no.61485) has been initiated and completed by the end of 2019 which included an adjustment of the used glue as well as an improvement of the assembly of the affected screw.This is the only complaint since that change.It is possible that an individual failure during the repair in may 2020 led to the loosening of the screw.There is no indication for a systematic failure based on the market surveillance.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
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