The subject product was returned to omsc for investigation.The investigation confirmed that the device could be turned on without problems.As a measurement result of the resistance value between the knife wire and the plug of the operation part, there was no anomaly.The knife wire was burned.The device history record for the lot indicated no anomaly with the event-related items below.Dc resistance value of the knife wire.The exact cause could not be determined.Based on the past similar cases, following possibility is considered as the cause that the device could not be turned on.Foreign materials adhered to the knife wire.The target site was immersed in liquid.Bodily fluids and tissues burned due to factors such as output for an extended period and the scorch stuck to the knife wire.The device instruction manual has warned the users follows.Before use, prepare and inspect the instrument and a cord as instructed below.Should any irregularity be observed, do not use the instrument or a cord; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, perforations, bleeding, mucous membrane damage, thermal injury and may result in more severe equipment damage.
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Olympus medical systems corp (omsc) was informed that, the physician tried to open the papilla with the device during ercp, but could not turn on the power.The physician canceled the procedure because the physician could not turn on the power even if replaced with another device and peripheral equipment.At a later date, the procedure was completed with still another device of same model.Two mdrs are submitted for incidents involving two devices on the single patient.This report describes the first of the two devices.
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