On (b)(6) 2017, an independent sales agent for rwmic, the us distribution partner for rwgmbh, was observing a surgery at the above mentioned facility when he received a complaint regarding an adverse event.Event was described as follows: on (b)(6), an unknown procedure was performed on a patient (possibly a transurethral resection of prostate (turp) or bladder tumor (turbt)) and patient started to bleed in post-op recovery room.Patient was transferred back to or in order to stop the bleeding.After bleeding was presumably stopped, patient was transferred to post-op where bleeding resumed or became more pronounced.Patient was returned to the or for the second time following the initial surgery at which time bleeding could not be stopped and the patient expired.Complainant did not allege that the rwgmbh instruments were suspected of causing or contributing to the patient's expiration.Additionally, hospital resumed use of the same devices for another surgery on (b)(6) 2017.No additional complaints or problems with any rwgmbh instruments associated with this event have been reported since that time.Attached is a list of known devices used during the (b)(6) 2017 procedure.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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