Brand name: hf-resection electrode, loop, 24 fr., 0.2 wire, 30°, sterile, single use, 12 pcs.Pma/510k: k790071/ k903323/ k951863/ k954488.Related patient identifiers: patient identifier: (b)(6) addresses event date on (b)(6) 2023 and patient identifier: (b)(6) addresses event on (b)(6) 2023.The device was returned to olympus for evaluation.A visual inspection confirmed that the loop was missing from the forks on the distal; the distal end was observed under a microscope, there is indication of burnt marks as well as melted insulation on the forks; the forks are slightly bent and deformed; the shaft as well as the proximal end have no indications of bends, kinks, or other signs of damages, and the stabilizing tube appears to have no deformities.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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An olympus representative reported, that during a therapeutic procedure for a trans-urethral resection of prostate, the wire on the distal end was frayed.The procedure was completed using a similar device.There were no reports of patient harm associated with this event.
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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.Based on the results of the investigation, it is likely that the cause of the reported issue is due to wear and tear.The instructions for use state: "use only compatible equipment as listed in this section.If other combinations are used, the full responsibility is assumed by the user.Risk of injury.If any damage to the insulation at the electrode¿s distal end becomes visible during use, replace the electrode with an undamaged electrode.Otherwise, there is a risk of injury for the patient and/or user.Risk of death or serious injury.Improper use of hf current can cause endogenous or exogenous burns, and explosions.Thoroughly review the hf current safety information included in the olympus endoscopy system guide." olympus will continue to monitor field performance for this device.
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