During a gastric endoscopic submucosal dissection, three subject devices were used.The distal tip of the first subject device was fallen off into the patient.Therefore, the doctor exchanged for the second subject device.But the similar phenomenon occurred on the second subject device.The fragments were not retrieved.The intended procedure was completed with the third device.No patient injury was reported.This is the second of two reports.
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This is a supplemental report for mfr report # 8010047-2016-01595 to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The distal tip of the subject device was missing.As the result of checking the manufacturing record of the same lot, there was nothing abnormal found.Based on the similar cases in the past, it was known that the distal tip of the subject device might be broken and missing, since electric discharge occurred and temperature of the distal end of the subject device increased while the high frequency output was activated.Also, it was known that electric discharge might occur, because the electro surgical unit was used in the coagulation mode, the high frequency setting value was too high, the activation time was too long, or the contact length between the cutting knife and the tissue was too short.The instruction manual of the subject device warns; *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.Cross reference mfr.Report number: 8010047-2016-01586.
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