The device was returned to olympus for evaluation and repair.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.Additional pma/510(k): k931995.
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Corrected fields: b5 (information was inadvertently missed), d9 (date returned), g2 (added selection).This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, device evaluation, and additional information obtained from the customer.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The ceramic beak at the tip of the sheath was broken.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, the root cause could not be determined.It is likely the damage was caused by one of the following; a thermal/mechanically induced impact, wear and tear, improper handling, and/or a mechanical overload (such as impact from a fall, shock, or similar stress).It was further noted that it cannot be determined with certainty, whether there was pre-existing damage or if it had occurred during the last procedure or last reprocessing.The instructions for use (ifu) provides a warning that the ceramic tip can break due to mechanical loading or thermally induced straining: ¿4 before use: warning: infection control risk properly reprocess the product before first and each subsequent use following the instructions in this manual and in the system guide endoscopy.Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.4.1 inspection and testing inspecting the product visually inspect the product.Make sure that it has: no corrosion, no dents, no scratches, ceramic insulation at distal end visually inspect the ceramic insulation at the sheath¿s distal end before each use.Do not use the instrument in case of damage (e.G.Cracks, fractures).Warning: risk of injury.Impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries to the patient and/or user.Do not use the instrument if damaged.Damaged product if the product is damaged or does not function properly, contact an olympus representative or an authorized service center.¿ olympus will continue to monitor field performance for this device.
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