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 wa22557c.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, the cause of the reported event is likely not due to the electrode, but to a defective, non-olympus hf-cable.However, the subject device was not returned to olympus for evaluation.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.
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