The device was returned and evaluated, and the customer¿s allegation was confirmed.In addition to the ceramic tip being damaged, the tube had 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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The customer reported to olympus that the inner sheath, for 26 fr.Outer sheath outer shell was damaged.The event occurred during preparation for use in a diagnostic procedure.The procedure was completed with a similar device.There was no patient harm associated with the event.The device was evaluated, and it was found the ceramic tip was damaged.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.
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