The scope was returned to the original equipment manufacturer (oem) for further investigation.The bending tube was confirmed to be bent towards the up-side as the angulation system was straining continuously between the 1st and 3rd cable support from distal tip.In addition, the 3rd cable support was detached on up-side of bending section.And the up-angulation coil in control unit was out of place.The exact cause of the reported event remains unknown, however, based on the investigation findings, the following factors can potentially contribute to the cause: bending unit not working.(during procedure).Extreme bending.(during procedure).Repeated angulations.(user handling).Strained a-wire.(variation in production).Longer length of coil-pipe.(variation in production).As a preventive measure, the instruction manual indicates the following chapter 4 operation:4.1 precautions: never insert or withdraw the endoscope under any of the following conditions.Patient injury, bleeding, and/or perforation can result.For example, while the endotherapy accessory extends from the distal end of the endoscope (except for using an ureteroscope sheath dilator).While the bending section is locked in position.Insertion or withdrawal with excessive force.
|