The device referenced in this report has been returned to olympus medical systems corp.For evaluation.During the evaluation, it was confirmed that there was malfunction in the angulation mechanism and, rupture and turnover of the bending rubber.The followings were also confirmed: -corrosion inside the bending section -damage in the bending tube -fixation and corrosion of the angulation wire in the insertion section and grip section -corrosion inside the grip section -corrosion inside the venting connector -corrosion at the instrument port.Corrosion was found in the subject device, but there was no irregularity in the instrument channel such as a pinhole.The manufacturing record of the device was reviewed with no irregularity relating to the phenomenon.The exact cause of the event could not be concluded at this moment however, it might be a possible cause that the bending rubber was cut by calculus and the bending rubber was turned up when the subject device was tried to be removed from the patient, then the subject device got stuck.
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Olympus was informed that the subject device got incarcerated and stuck in the patient ureter during a f-tul (transurethral ureterolithotomy) procedure.The subject device was inserted into kidney for a ureteroscopic examination without a laser or a therapeutic device inserted into the instrument channel of the subject device.After that, the user felt the subject device to be caught when the user was trying to withdraw the subject device, and the user could not remove the subject device.Therefore, the user performed an open surgery to cut the ureter so that the subject device became movable, and removed the subject device.During the surgery, the user retrieved a part of the bending rubber that fell off during the procedure.The procedure was completed after the user inosculated the ureter of the patient.The user commented that the subject device seemed to get stuck by surrounded with fine sand-shaped calculus.
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