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Model Number A22040A |
Device Problem
Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The customer originally returned his olympus inner/outer sheath due to unspecified damage to the device.There was no patient harm reported as a result of the above event.During the device evaluation, it was discovered that the beak had scratching on the inside of the tip.This report is being submitted to capture the scratching damaged confirmed during the devic evaluation.
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Manufacturer Narrative
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The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.As noted in b5, there was scratching discovered on the inside of the tip of the unit¿s beak.Additionally, insufficient sheath insertion was noted as well as mandolin malfunction.If additional information becomes available following the device evaluation, a supplemental report will be filed.
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Manufacturer Narrative
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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 reportable malfunction occurred due to thermal induced impact, wear and tear, improper handling, mechanical overload like fall, shock or similar stress.The event can be prevented by following the instructions for use (ifu) which state: "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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Search Alerts/Recalls
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