The suspect medical devices were not returned to olympus for evaluation/investigation since they were reportedly discarded by the user facility after the procedure.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, (b)(4) is implementing a removal action of specified lot numbers of the monopolar hf resection electrodes (b)(4).The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.(b)(4) has initiated this removal action after receiving an increased number of complaints regarding loop wires breaking at the distal end of the referenced electrodes.Investigations have confirmed that loop wires can break during the intended use of the electrodes.As a result, a fragment may fall inside the patient and will need to be retrieved.Retrieval of the fragment could prolong the procedure and, under certain circumstances, could require additional surgical treatment.The investigation revealed that the loop wires of the affected electrodes were damaged during production.The cause of this damage is defective manufacturing equipment.The damaged loop wires cannot be detected by visual inspection.There has been no report to date of an adverse event or patient injury.However, in an effort to prevent a potential risk to patient health, (b)(4) is undertaking this action to remove the affected lot numbers.(b)(4) correction number according to 21 cfr 806.10 (c) (1): 2429304-4/18/2017-044r.
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Olympus was informed that during a therapeutic transurethral resection (tur) procedure, the loop wires of two hf resection electrodes from the same lot broke off and fell inside the patient.However, no fragments remained inside the patient since they were reportedly retrieved.The intended procedure was successfully completed with another hf resection electrode and there was no adverse event or patient injury.This is report 3 out of 3.
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