The device was returned and evaluated, and the customer¿s allegation (ceramic tip loose) was confirmed.In addition, the sealing ring was damaged and the switches were corroded and loose.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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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.As a general note, cracks on the insulation material are mostly not visible, making visual inspection difficult.Lost fragments of the ceramic insulation insert can be localized and removed using a suitable x-ray procedure or computed tomography.Damaged sealing ring: the reported issue was most likely caused by wrong handling by the user.The damage to the sealing ring is most likely attributable to frequent use and poor maintenance/wrong reprocessing.A damaged sealing ring is very likely to cause the inner sheath to leak.Corroded and loose switches: the reported issue was most likely caused by wrong handling and the use of excessive force by the user.The corroded/loose switches are most likely attributable to rough handling, incorrect reprocessing and poor maintenance.The following is included in the device 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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