The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: flow was not adequate during vessel harvest had to convert to open to harvest the vessel probable root cause: because device was not returned to oem - wom, probable root cause cannot be determined.The most probable root cause is, that (a) the blue so called one-way valve of co2 lnsufflation port on the vasoview hemopro 2-device is too short or misplaced, so the luer lock cone could not press the one-way valve to open or (b) the luer lock was not properly tightened to open the one-way valve on the co2 distal insufflation port on the vasoview hemopro 2- device.Expanded investigation activities not possible because the device was not returned for evaluation.However, tests on w.O.M.-r&d, which had been proceeded with pneumoclear-lnsufflator, pneumoclear tube set and a vasoview hemopro 2-device, concluded the following: ¿ the maximum flow is about seven liters per minute at an adjusted flowrate of ten liters per minute ¿ the main reason for this limitation is due to the very thin hoses of the vasoview hemopro 2-device (id approx.2mm) ¿ if the tube set will be correctly tightened, then the cone of the luer lock will move the blue valve stick at the co2 distal insufflation port about 1.5mm ¿ at approx.0.5mm movement of the blue valve stick, the valve will be opened sufficiently to reach the above-mentioned flow rates ¿ it was not possible to generate a scenario that the tube is tightened and there is no flow the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
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