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Getinge became aware of an issue with our column - 116001a0 - otesus or table column, stationary.The following was reported to us.Failures have occurred in various operating table columns of the otesus system.According to the customer, these failures took place during and immediately before the operation.This prevented the patient from being repositioned or made it more difficult to evacuate the patient.No injuries have been reported to us in connection with these failures.We found out about problems with the otesus system in this clinic on july 12th, 2021.On july 28th, 2021 we learned from the operator report that there were major difficulties during the surgery.We asked the clinic for further information, such as the affected serial numbers and the incident data, but did not receive it.We have received information from the clinic that this data cannot be made available to us.We decided to report the issue due to customer allegation regarding major difficulties and delays during surgery.It was established that when the event occurred, the column did not meet its specification, which contributed to the event.The device was being used for a patient¿s treatment upon the event occurrence.The review of received customer product complaints revealed that there was one similar complaint related to this issue.Comparing the number of complained devices (9) to the number of units placed on the market up to the end of july 2021 (3832) we can conclude the failure ratio is 0,23% for the investigated issue.According to the hospital, the connection sockets for the cable operating devices are not adequately protected against the ingress of cleaning liquid.The user is warned in the instructions for use (ifu) to ensure that no liquid can penetrate live parts.With regard to cleaning the operating table, a warning is given not to spray cleaning agents directly into joints or cracks and not to use high-pressure cleaners.The table failures described occur when enough conductive liquid has entered the affected socket to create a short circuit between the contacts used.This occurs if the resistance is less than 400 ohms.The sockets are not located vertically on the operating table but on a housing with a negative incline.Due to this position, the socket is additionally protected against dripping / running down liquid.The cleaning of the operating tables is described in the ifu.We assume that non-observance of the ifu has led to the error pattern described.The bushings may have been damaged and the tables continued to be used.In the instructions for use (ifu), the user is advised that a visual and functional test must be carried out before each use of the operating table.If damage to mechanical parts, such as the connection sockets for the cable operating devices mentioned, is found during this check, the product can no longer be used.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The event has been reported with a delay due to our retrospective examination of the record.At the time (2021) the complaint was reviewed and found not to be reportable in the us.Current day, we compared the registration list, and found an inconsistency with the reporting decisions.With the current knowledge and the current team of complaint handlers, we have come to conclude the event should have been reported.As a remedial effort, we have reported it now.Device not returned to manufacturer.
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Getinge became aware of an issue with our column - 116001a0 - otesus or table column, stationary.The following was reported to us.Failures have occurred in various operating table columns of the otesus system.According to the customer, these failures took place during and immediately before the operation.This prevented the patient from being repositioned or made it more difficult to evacuate the patient.No injuries have been reported to us in connection with these failures.We found out about problems with the otesus system in this clinic on july 12th, 2021.On july 28th, 2021 we learned from the operator report that there were major difficulties during the surgery.We asked the clinic for further information, such as the affected serial numbers and the incident data, but did not receive it.We have received information from the clinic that this data cannot be made available to us.We decided to report the issue due to customer allegation regarding major difficulties and delays during surgery.
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