This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: d9,g3, g6, h2,h3, h4, h6 and h10.The returned device was received and evaluated.Inspection found the device did have dried blood that wrapped around the distal end of the probe.The blood seemed to be only covering part of the gold electrode tip.The device distal tip was cleaned to remove any of that dried blood before testing the functionality of the probe.The device was plugged into a generator and tested for coagulation.Using a piece of meat, the coagulation feature was able to heat up and coagulate the meat.There was a kink in the wiring, however, upon opening up the wire to see if there was any damage, it was observed that there was no damage to the actual wiring itself.Since the device was able to heat up and coagulate, the initial complaint cannot be confirmed.The observed failure is a known phenomenon resulting from an insufficient level of coagulation.Page 6 of the device ifu (instruction for use) (p9100505-001_ah) addresses this: "insufficient generator output time or generator output level may not provide the operator with the desired level of coagulation".Olympus will continue to monitor the field performance of this device.
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