This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide a correction to the initial with information inadvertently left out (b5, e2, e3, and g2).Although the subject device was not returned to olympus, the provided pictures confirm the subject device is 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, it is likely the reported event occurred due to wear and tear, wrong handling, or cracks in the insulation material, which are not visible in most cases.Additionally, it is possible that the described issues were caused by the impact of a major mechanical force, e.G.A blow or a fall.Based on the nature of the damage, it is likely that this is a thermo-mechanically induced damage.It is unclear whether the insulation insert had a previous damage or wear and tear through reprocessing or from the last procedure.However, the root cause of the reported event could not be identified with the information received.The event can be detected and/or prevented by following the instructions for use which state: -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." "inspection and testing¿ olympus will continue to monitor field performance for this device.
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