The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, coated portion of the cutting wire was torn, and the broken portion was scorched and melted.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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A user facility reported to olympus, that the single use 3-lumen sphincterotome v had broken knife wire.It was reported that the device was replaced with similar device from the same lot and the knife wire from the replacement device was also broken.The event occurred during and endoscopic papillotomy procedure.According to the report, the procedure was completed using a third-party device.There were no reports of patient harm associated with this event.This complaint is for the replacement lot and related to patient identifier (b)(6).
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported device problem.The outer diameter of the cutting wire was measured.The result indicated no abnormalities.The length of the cutting wire and the coated portion was measured.The distal side of the coated portion was missing approximately 4.5-6.5 mm.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported device problem.No abnormalities were noted in the dhr for the following that directly related to the reported event: - length of cutting wire - length of coated portion - operation of cutting wire 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 cutting wire, at a torn area of the coated portion, came into contact with the distal end of the endoscope while the forceps elevator was raised.2.The output was activated as described in (1), and the cutting wire became hot instantly.This caused the cutting wire to break.The tear of the coated portion of the cutting wire was reproduced.It was thought that the tear occurred according to the following mechanism: 1.The forceps elevator of the endoscope was raised.2.When the cutting wire deflects, the coated portion of the cutting wire and the metal part of the distal end of the endoscope come into contact.3.As described in (2), the cutting wire was moved back and forth.This caused the coated portion of the cutting wire to tear.Additionally, the slider was pushed more than needed.This caused the cutting wire to deflect.It was inferred from the investigation that some a force was applied to the coated portion of the cutting wire when the device was withdrawn from endoscope (after the coated portion of the cutting wire had torn).This may have caused the coated portion of the cutting wire to detach from the cutting wire.As a result, the coated portion was partially missing.A definitive root cause for the reported product problem was not established.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.- be sure that the rear end of the cutting wire is extended from the distal end of the endoscope.In case the cutting wire contacts the forceps elevator, insufficient output or unintended tissue injury may occur.- do not activate output while the cutting wire touches the metal parts of the endoscope, or they are being close together.This could burn the tissue and/or damage the endoscope or the instrument.¿ olympus will continue to monitor field performance for this device.
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