LAPRA-TY

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE CLIP WAS USED. THE DEVICE WAS ATTACHED TO THE APPLIER, BUT IT COULD NOT GRASP THE SUTURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. SIX DEVICES WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION PROVIDED: NONE OF CLIPS IN THE ENTIRE PACK COULD GRASP THE SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE THE APPLIER PRODUCT CODE AND LOT NUMBER? KA200. PLEASE CONFIRM IF THERE IS AN ISSUE WITH THE APPLIER? NO. WHAT SUTURE TYPE AND SIZE WAS USED? UNK. WHEN THE EVENT OCCURRED, WAS THE SUTURE PLACED NEAR THE HINGE OF THE CLIP? UNK. WERE YOU ABLE TO LOCK THE CLIP CLOSED ON THE SUTURE? UNK. IF YES, AFTER IT CLOSED, WAS THE CLIP HOLDING SECURELY FIXED ON THE SUTURE? WAS THE APPLIER CHECKED FOR DAMAGED (JAWS STRAIGHT AND ALIGNED)? UNK. IF THE CLIP DID NOT CLOSE/HOLD ON THE SUTURE, WAS THE CLIP USED IN AN APPLICATION WHERE THE SUTURE WAS UNDER TENSION? UNK. PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. WE REGULARLY CONTACT SALE REP ABOUT THE DEVICE RETURNING. PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS (NOT THE PERSON RELAYING/SUBMITTING ANSWERS TO LOC OR CHU). HIROMI TOKUYAMA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.