The subject device was returned to olympus medical systems corp.(omsc).The factory of aomori olympus confirmed that the cutting wire of the subject device was broken.The broken section of the cutting wire was melted and burned.The coating on the cutting wire was torn.As a measurement result of the outer diameter of the cutting wire, there was no abnormality.There were no missing parts.The manufacturing record was reviewed and found no irregularities.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 to the metal part of the forceps elevator while the device was activated the output.Then, a part of the cutting wire became extremely hot, resulting in breakage.The above device handling has warned in the instruction manual as follows.*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.*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.*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.
|