The device has not been returned to omsc but was returned to (b)(4).As a result of the evaluation, (b)(4) confirmed the angulation wire for down direction of the device was snapped at the distal end.However, the exact cause of the reported event could not be conclusively determined.Omsc reviewed the manufacturing history of the device and confirmed no irregularity.
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Olympus medical systems corp.(omsc) was informed that during a therapeutic procedure (laser liver plasty) using the subject device and laser device in combination, the angulation wire of the device broke.Because the user facility had no alternative device, the intended procedure was canceled.There was no patient injury associated with this report.In addition, the user facility reported that there was no problem when inspection before use of the device was conducted.
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