This report is being supplemented to provide additional information regarding the event, the device evaluation, and information that was inadvertently not provided in the initial medwatch report.G3 was blank on the initial report and should have been jan.12, 2022.The device history record was reviewed and no issues were identified that could have caused or contributed to the reported issue.The instrument was returned and it was confirmed that the sheath had come detached from the handle.Based on the results of the investigation, there will be a sheath anchoring and adhesion design change to address this issue.Veran will continue to monitor field performance for this device.This supplemental report is being submitted as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.
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