The customer reported to olympus that an electrical failure occurred and no image during the hysteroscopic myomectomy and the same problem occurred after replacing all the combined devices causing a 30-minute delay in surgery and 30 minutes extended anesthesia time.There were no error messages.The procedure was completed using other urological products.The event did not affect the diagnostic or treatment outcome.There were no reports of patient harm.This event requires 12 reports.Related patient identifiers for the first combination of devices used are as follows: (b)(6) (wa00014a / hf-cable, bipolar), (b)(6) (wa00014a / hf-cable, bipolar) , (b)(6) (a42011a / resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs), (b)(6) (a42021a / outer sheath, 8.5 mm / 26 fr., 2 stopcocks, rotatable), (b)(6) (wa22366a /working element, active, for resection in saline), (b)(6) (wb50402w / foot switch, double, for, esg-400).Related patient identifiers for the second combination of devices used: (b)(6) (wb50402w / foot switch, double, for, esg-400), (b)(6) (wa22366a / working element, active, for resection in saline), (b)(6) (a42011a / resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs), (b)(6) (a42021a /outer sheath, 8.5 mm / 26 fr., 2 stopcocks, rotatable), (b)(6) (wa00014a / hf-cable, bipolar), (b)(6) (wa00014a /hf-cable, bipolar).This medwatch report is for 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 and device evaluation.The device was returned to olympus for inspection, and the customer¿s complaint could not be reproduced.The evaluation findings are as follows: there were no abnormalities observed.In addition, no electrical problems were confirmed, and the output was normal.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the cause of the reported issue could not be determined as no device fault or malfunction was identified by olympus.Although no device problem was detected, potential causes for poor conductivity may be dirt adhering to the electrodes (impairing conduction), a temporary poor connection of the device, and/or an abnormality in the high-frequency power.Olympus will continue to monitor field performance for this device.
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