This report is being supplemented to provide additional information based on the device evaluation and 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.It has been over six (6) years since the subject device was manufactured.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that worn toric joints was due to wear and tear.For the broken tip the most likely causes are: thermo-mechanical fatigue wear and tear improper handling (impact, shock) the event can be detected/prevented by following the instructions for use which state: before using the product, the warning notices in the instructions for use should be followed to ensure a faultless condition of the product.See especially chapter 4: 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 and 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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