A report of the probe breaking during an ilogic electromagnetic navigation bronchoscopy (enb) procedure was reported.The user, placed the ultrasound probe down the ilogic catheter without incident, however upon removing the probe from the catheter the outer sheath separated from the probe.The user was able to successfully remove the piece that separated, reporter stated that nothing fell into the patient.There was no patient harm or injury reported due to the event.No user injury reported.
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This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the results of the investigation, it is presumed that external force may have broken the sheath.As stated on the ifu (instruction for use) the user manual states: do not hit, stretch, twist, drop, or bend excessively the distal end, insertion section, or connector section of the ultrasonic probe.Otherwise, the equipment may be damaged, causing an injury in the body cavity, burns, bleeding, perforation, or detachment of parts.Olympus will continue to monitor complaints for this device.
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