International safety notice

Due to product testing at overseas manufacturers, the articulation of certain lot number products is malfunction occurs and the jaw is unable to maintain its angle, resulting in the jaw moving in an unintended direction with the jaw closed. The phenomenon of bending was confirmed. This event occurs when the handle (Endo GIA Ultra Universal Stapler or Signia Stapler) is used with the product. After connecting the needle to the pulling system and completing the needle driving in the bent state, continue the needle driving operation (furthermore, the hand This may be caused by squeezing the center control or holding down the center control. vinegar. To date, there have been no complaints reported regarding this event in Japan or overseas, but in verifying the event, When we continued the needle injection operation after completing the needle injection into the tissue, we found that it was reproducible, so we decided to conduct a voluntary recall. That's what I said.

Japan / PMDA Recalls · JPN · Feb 19, 2024