A user facility reported that after twenty minutes into a transurethral resection of bladder (turb) while using hf-resection electrode, button, 24-28 fr., 12° and 30°, sterile, single use, 12 pcs., along with the working element, there was no resection.The doctor instructed the nurses to check the saline solution and it was ok so they attempted again with success.There was a unexpected loud sound followed by smoke.It was stated that the physician was scared and swiftly pulled the instrument from the patient resulting in a bladder perforation.The procedure was transitioned to an open procedure to close the perforation.The patient was stated to be stable after the open surgery.This mdr requires 2 reports.The related patient identifiers are as follows: (b)(6): hf-resection electrode, button, 24-28 fr., 12° and 30°, sterile, single use, 12 pcs., for turis, model wa22557c.(b)(6): working element, passive, for resection in saline, model wa22367a.This medwatch report is for patient identifier (b)(6), model wa22367a.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (updates to field d9, g2, and h3).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.The complete evaluation results are as followed: missing electrode seal at the main body of the working element and non-olympus high frequency cable.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, it is likely the suggested event occurred due to a defective, non-olympus high frequency cable.However, the specific root cause of the suggested event could not be identified.Olympus will continue to monitor field performance for this device.
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