The device was returned to olympus for evaluation and in addition to the reportable malfunction documented in b5, the remaining evaluation findings were as follows: due to wear of scope cover, water tightness was lost; flexibility adjustment ring, switch box, objective lens, and grip had a scratch; light guide lens had a crack and scratch; air/water cylinder and suction cylinder had no color; due to wear of angle wire, the play of up/down knob was out of the standard value; connecting tube had coating peeling; universal cord had a wrinkle; and screw stopper was replaced for preventive maintenance.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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The customer reported to olympus, the colonovideoscope had possible water ingress, no image.The device was returned for evaluation.During testing and inspection of the device, the following reportable malfunction was found: jet tube had foreign objects (white foreign material) and plug unit corroded resulting in communication error e315.There were no reports of patient harm or impact associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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This supplemental report is being submitted to provide the legal manufacturer's final investigation.A review of device history records and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue was identified.The e315 error was most caused by damage due to user handling.This likely resulted in water invading the device from the damaged location, and further damaging the circuit board inside the scope connector.The foreign material found was most likely as a result of improper reprocessing due to water tightness being loss and wear of the scope cover.However, the root cause of both reportable malfunctions could not be specified.The event can be prevented by following the instructions for use which state: "chapter 3 preparation and inspection the equipment prepared before using this endoscope and procedures for inspection of the endoscope and equipment are described in this chapter.3.1 the workflow of preparation and inspection the workflow of preparation and inspection is shown below.Before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5, ¿troubleshooting¿.If the endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Warning ¿ never use the endoscope on a patient if any irregularity is observed.The irregular endoscope may compromise patient or user safety and may result in more severe equipment damage.In addition, it may pose an infection control risk." "chapter 5 troubleshooting the countermeasures against troubles are described in this chapter.5.1 troubleshooting if any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2, ¿troubleshooting guide¿.If the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described in section 5.3, ¿withdrawal of the endoscope with an irregularity¿.Warning ¿ never use the endoscope on a patient if any irregularity is observed.The irregular endoscope may compromise patient or user safety and may result in more severe equipment damage.In addition, it may pose an infection control risk" olympus will continue to monitor field performance for this device.
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