During an endoscopic submucosal dissection, the subject device was used.In the procedure, the distal end tip broke off and fell inside the patient.The physician decided not to retrieve the fragment since it will be discharged spontaneously.There was no patient injury reported.No further information was provided.This is the report regarding the breakage of the distal end tip.
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This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The tip of the distal end was lost.The remaining adhesive was applied to all around the distal end and the amount of adhesive was enough.The surrounding of the electrode was burnt black, which is assumed to have occurred due to electric discharge.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the temperature of the cutting knife increased and adhesive strength between the tip and the electrode weakened since the electric discharge occurred between the electrode and the tissue when the user activated high-frequency output, besides the tip fell off when the distal end was subjected to a load during user handling.It was also known that an electric discharge occurred due to the following reasons; the electrosurgical unit was used in the coagulation mode.The high-frequency output was set too high.The time of output was too long.The contact length between the cutting knife and the tissue was too short.The above device handling has been warned in the instruction manual as follows; *when the electrosurgical unit is used in the coagulation mode, crack/detachment of the tip and the electrode or deformation/break of the cutting knife could occur, for example when the high-frequency output is set too high or the length of the contact between the cutting knife and tissue is too short.During treatment, always ensure that the slider slides on the handle smoothly and that the electrosurgical knife observed in the endoscopic image is normal.Should cracks or detachment of the tip or deformation/break of the cutting knife be detected during use, immediately shut off the power supply, discontinue the procedure, pull the slider and withdraw the endoscope from the patient with the cutting knife retreated in the insertion portion of this instrument.Do not continue using an abnormal electrosurgical knife to prevent perforation or hemorrhages.If the tip or cutting knife is detached be sure to collect it using grasping forceps.
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