The subject device was not returned to omsc (olympus medical systems corp.) for evaluation since it was discarded by the user facility.We assumed the subject lot from the delivery date since the lot was unclear.The manufacturing history record of the lot was reviewed, with no irregularities noted.The doctor said that the incision direction of papilla was improper and it was not due to the device problems.Therefore, the improper incision by user handling caused this event.The instruction manual of the device has already warned as follows; do not insert the instrument into the endoscope unless you have a clear endoscopic field of view.If you cannot see the distal end of the insertion portion in the endoscopic field of view or in x-ray images, do not use it.This could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It may also damage the endoscope and/or instrument.
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During endoscopic sphincterotomy (est), the doctor abandoned the procedure due to perforation and loss of blood from the patient¿s papilla.However, the details of the treatment for perforation and bleeding were unspecified, but it was reported that a metallic stent was inserted into papilla to press injury part.The patient was hospitalized.
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