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 with correction to the initial with information inadvertently left out.Additionally, to provide updates to fields (d4 -lot number, d9, h3, and h4).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the reported issue could not be determined as no fault or malfunction has been identified with the affected devices.It is possible that the phenomenon occurred due to a combination article used caused the reported error.Additionally, incorrect handling by the customer cannot be ruled out.However, a specific root cause of the phenomenon could not be determined.Olympus will continue to monitor field performance for this device.
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