The device has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.To avoid injury to the patient, the device instructions for use document recommends ¿do not apply excessive force to advance or withdraw the guidewire.Doing so may result in complications.If resistance is encountered, determine the cause and take remedial action before continuing.¿ as a preventive measure against device damage, the instructions for use warn ¿do not reshape or alter the configuration of the guidewire.Doing so may compromise the structural integrity of the guidewire and may result in complications.¿ and ¿the tips of some metal instruments may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking.If this occurs, it is recommended that any fragments of the outer coating material be removed.While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument.¿ prior to use, the instructions for use also state that the device should be stored in a dark, cool, dry place.
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Olympus was informed via voluntary medwatch (b)(4) that on an unknown date in (b)(6) 2018, during a cysto urethral dil complex foley catheter replacement procedure, the wire unraveled while in the patient and while the clinician was removing the wire.There was no reported patient injury.It was reported that the patient had a pre-existing bladder cancer urethral stricture.
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