On 2nd march, 2022 getinge received the information about the event which was related to manual trolley universal wash cart 2000 that is used with the 91e-series washer disinfector.As it was stated on (b)(6) 2022 an operator reported a bruise on his foot during the extraction of the instruments from the highest shelf of the trolley.After the medical examination the operator was 7 days off work to recover from the injury.Based on the available information we cannot classify the health impact, however we decided to report the issue in abundance of caution and based on the potential as we cannot confirm that similar events could not contributed to the serious injury if reocur.
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On 2nd march, 2022 getinge received an information about the event which was related to the 91e-series washer disinfector.The device involved in the incident was the universal wash cart 2000 trolley which cooperated with one of the three washer disinfectors.It was not possible to determine which exact washer disinfector was involved in this particular incident.On (b)(6) 2022 in the customer facility, operator bruised his foot during the activity of extracting the containers from the highest shelf.After the event the operator had a medical examination at the emergency room.The operator was given 7 days off work to recover from the injury.Trend review of customer product complaints with the same issue involved on this type of devices reported within the last 5 years was performed but did not provide any signals that would warrant further scrutiny.As a result of performed investigation we could establish that the most probable root cause of the event is related to a user error due to not following the manufacturer's recommendations contained in the user manual (doc.Id 6001855402 rev.J), which resulted in overloading the trolley.We report the event in abundance of caution and based on the potential for a serious injury if the situation was to reoccur.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.
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