Centra

Description of Event or Problem

The user facility reported that during a patient procedure user facility personnel were having trouble grabbing the tissue with their Centra Biopsy Forceps subsequently causing the patient to obtain a hematoma. The procedure was completed successfully utilizing the same device.

Additional Manufacturer Narrative

The device subject of the reported event was not returned to STERIS for evaluation. Without the returned device, a cause of the reported event could not be determined.A complaint review was conducted for this lot of products and confirmed this to be an isolated event.User facility personnel received in-service training on the proper use and operation of the Centra Biopsy Forceps.No additional issues have been reported.