A visual examination of the returned capio slim revealed that the device did not have any visual failure.The carrier was actuated (deployed) and it extended and retracted without any issue.It was also actuated three times with the suture, and the needle entered in the slot.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Based on all gathered information and investigation results, there is no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore, the reported issue was unable to be confirmed.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
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