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Model Number A22040A |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2023 |
Event Type
malfunction
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Event Description
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The customer reported that an inner sheath, for 26 fr.Outer sheath had a damaged distal end.There was no procedural delay, or no patient harm associated with the event.The device was returned and evaluated, and upon estimation, the ceramic tip was damaged.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
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Manufacturer Narrative
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The device was returned and evaluated, and the customer¿s allegation (damaged distal end) was confirmed due to a damaged ceramic tip.In addition, the tube had slight dents.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
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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 improper handling by the user (more specifically the device being subjected to mechanical overload, impact, accidental dropping, etc.).It could not be determined if there was pre-existing damage to the insulation insert or if it was already worn.Furthermore, it cannot be determined if the damage was caused during the last reprocessing of the instrument or during its last use in a procedure.Lost fragments of the ceramic insulation insert can be localized and removed using a suitable x-ray procedure or computed tomography.Dented tube: the reported issue is most likely attributable to the device being subjected to excessive mechanical force due to an impact or accidental dropping.The following is included in the device instructions for use (ifu): "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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