This supplemental report is being submitted to provide additional information based on the legal manufacturer's final investigation.Correction to the g3 aware date in the initial medwatch.The aware date should have been 04sep2023.The h6 medical device problem code field was also updated to "3020 - scratched material." 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 damage to the ceramic beak of the sheath was caused by thermal induced impact, wear and tear, improper handling, or mechanical overload like a fall, shock or similar stress.The event can be detected and prevented by handling the device in accordance with the instructions for use which state: ¿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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