The device referenced in this report has not been returned to olympus for evaluation.The exact cause of the reported user's experience could not be conclusively determine at this time.The instructions for use warns users: if the angulation control mechanism or any other part of the system is not functioning properly, stop the procedure immediately and place the up/down angulation lock in the free "f " position.Then carefully withdraw the endoscope while observing the endoscopic image.If the endoscope cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it; leave it inside the patient and immediately contact olympus.Forcibly withdrawing the endoscope may cause patient injury." if additional information is received or if the device is returned at a later time, this report will be supplemented.
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Olympus was informed that during a diagnostic cyctoscopy procedure, the physician was about to view the bladder when the bending section became irreversibly locked while inside the patient's urethra.As the physician began flexion of the device, a "snap" was heard and the bending section continued to flex and would not return to the straight position.It was reported that the device was stuck inside the patient for close to two hours.The insertion tube was manually cut in half to release the flexion and allow for removal of the device from the patient.There was no patient injury reported, just minor bleeding.The physician aborted the procedure and did not continue after the scope was removed.No additional information was provided.
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