The subject device was manufactured on april, 2021 based on the provided 3 digit lot information.The device was forwarded to the legal manufacturer for a physical evaluation.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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Correction to g3 of the initial medwatch (mfr#8010047 2022 07930).The aware date should be 11-apr-2022.This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The investigation confirmed the reported device problem.The cutting wire was broken on the proximal side.The broken portion was scorched and melted.The outer diameter and length of the cutting wire were measured and found to be normal.A review of the device history record found no deviations that could have caused or contributed to the reported device problem.A definitive root cause for the reported product problem was not established.However, it was probable that the issue occurred according to the following mechanism: 1.The device was not protruded enough from the endoscope until the rear end of the cutting wire was in the field of view.2.As described in (1), the cutting wire and the endoscope were close to each other.3.The output was activated as described in (2) and this might have led to an electrical discharge between the cutting wire and the distal end of the endoscope.4.An electrical discharge possibly occurred, and the cutting wire became hot instantly.This may have caused the cutting wire to break.The occurrence of the reported incident can be prevented by adhering to the instructions for use (ifu), which state the following: ¿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.¿ olympus will continue to monitor field performance for this device.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
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