The customer reported to olympus, the olympus resectoscope sheath was missing a screw on the inner cylinder which caused detachment of the connection.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: there was scraping on the inside of the tip of the beak.There was no report of patient injury or medical intervention associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the device evaluation.
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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.However, the definitive root cause was unable to be determined.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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