The device was returned to olympus for evaluation.A visual inspection was performed on the received device and found the cutting wire broke off.Both sides of the broken wire were matched to each post and measured 20 mm in length; therefore, no portion was missing or suspected to be lost.Due to the returned condition of the device wire no further testing could be performed.The sphincterotome v instruction manual gives the user several warnings to mitigate this type of device damage.The ¿operation ¿section of the manual states ¿since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong.When the wire breaks off its proximal end it will retract towards the endoscope if the slider is pulled.If the slider is pushed, the wire will be pushed out toward the papilla or move sideways.If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube.Then withdraw the instrument from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct and/or damage of the endoscope could result.¿.
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