It was reported that the patient experienced bloody stool following an unspecified therapeutic procedure.Upon patient examination, the physician determined the loop of the device had come off.The physician attempted to stop the bleeding to no avail.As a result, the patient was sent to the hospital.Additional information is unavailable at this time.
|
This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device has been evaluated.All records indicate that the product was manufactured, tested in accordance with all applicable procedures, and met all final product release criteria.The instructions for use shipped with the device provides the user the following information related to the reported issue: in order to prevent the ligator loop from slipping off, care should be taken to ensure that there is adequate space remaining above the loop.Conclusion: the subject device was not returned for investigation.The exact cause of the reported event could not be identified.It can be inferred that the upper side of the ligation area did not have enough height.Therefore, the loop might have come off from the ligation area and bleeding might occur.
|