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Model Number A42011A |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/07/2023 |
Event Type
malfunction
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Event Description
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The user facility reported that the resection sheath was leaking.The issue was found during reprocessing.There was no patient or user harm reported due to the event.The subject device was returned to an olympus service center for evaluation.During inspection and testing, it was found that the ceramic tip was cracked.This report is being submitted for the malfunction found during the device evaluation.
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Manufacturer Narrative
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During the device evaluation, it was observed that the subject device was leaking due to a damaged sealing ring.The investigation is ongoing; therefore, a root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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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 event occurred due to wear and tear and/or improper handling by the customer (more specifically the device being subjected to mechanical overload, impact, accidental dropping, etc.) the event can be 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." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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