An olympus representative reported that a user facility was using an inner sheath during a procedure when the beak became dislodged.The ceramic tip broke off into the patient during a resection procedure.The tip was retrieved using grasping forceps.The procedure was completed using another resection sheath.No death, injury, or infection occurred as a result.No additional information has been obtained.
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This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, and review of production records from the last two years and a review of the device instructions for use (ifu) were conducted.The lot number is not available.However, the manufacturing and quality control review was performed for the last 24 months of production and there are no non-conformities or deviations regarding the described issue.The root cause was unable to be determined.Based on the described damage pattern, it is assumed the insulation tip damage was caused by mechanical thermal influence.Thermal mechanical overload, improper handling, and mechanical impact like fall, shock, or other stress could damage the insulation material of the sheath.The ifu warns that the ceramic tip can break due to mechanically loading or thermally induced straining.It is the responsibility of the user to inspect the instrument prior to ever procedure.The risk due to this event has been reviewed and no further actions are required.Olympus will continue to monitor for similar events.
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