The subject device was returned to olympus medical system corp.(omsc) for investigation.The investigation on (b)(6)2017 confirmed that the cutting wire of the subject device was broken.The broken section of the cutting wire was melted and burned.The coating of the broken section was torn.Additionally, the coating on the cutting wire was missing about 13.0 mm to the specification.As a measurement result of the outer diameter of the cutting wire, there was no abnormality.The device history record for the lot indicated no abnormality with the event-related items below.1) length of the pfa wire.2) appearance of the pfa wire.3) operation of the cutting wire.4) the overall appearance this type of damage is most likely related to the operator¿s technique.Based on the past similar cases, omsc assumes that the damage of the coating occurred due to contacting with the metal part of the forceps elevator of the endoscope.The exposed cutting wire from the damaged coating contacted or came close to the metal part of the forceps elevator while the device was activated the output, and it caused spark.Then, a part of the cutting wire became extremely hot, resulting in breakage.Omsc assumes that the broken coating on the cutting wire was caught and detached when the subject device was retrieved from the endoscope.As a result, the missing of the coating occurred.The instruction manual of the device has already warned as follows; 1) 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 will be retracted toward 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.2) when inserting the instrument into the endoscope, be sure that the cutting wire is parallel to the tube.Otherwise, the metal part of the forceps elevator may contact the cutting wire and peel off the coating material.3) do not activate output while tissue is in contact with the torn or damaged coated portion of the distal end.If output is activated while tissue is contacting the torn or damaged coated portion due to insertion into or withdrawal from an endoscope, leakage current, decreased output, and/or thermal injury could result.
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During an endoscopic sphincterotomy, the subject device was used.It was reported that the cutting wire of the subject device was broken after a short time of use.There was no patient injury reported.The subject device was returned to olympus medical system corp.(omsc) for investigation.The investigation on (b)(6) 2017 confirmed that the cutting wire of the subject device was broken.Additionally, the coating on the cutting wire was missing about 13.0mm to the specification.
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