The legal document did not specify a model, serial or lot number for any of the devices that allegedly attributed to the patient¿s outcome.Therefore, it is unknown if the device was returned to olympus for evaluation, service or repair.In addition, as part of our investigation olympus followed up with (b)(6) and was informed by the facility¿s vice president of quality management that the facility does not use olympus equipment and therefore, cannot provide any details regarding the mentioned patient or procedure.Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported events.If additional information becomes available, this report will be updated and supplemented accordingly.
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On (b)(6) 2018, olympus received a legal document that alleges during a cystoscopy with urethral dilation and transurethral resection/ablation of prostate with bipolar procedure, a patient sustained a thermal injury to the bladder and urethra.According the legal document, the patient was under anesthesia when the alleged injury occurred.It is unknown if the patient was treated or if intended procedure was completed.
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