LIGACLIP

Additional Manufacturer Narrative

(B)(4). DATE SENT: 6/23/2026. D4: BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: 1. WAS THERE ANY OTHER ISSUE NOTED WITH THE STAPLE LINE OTHER THAN BLEEDING (MALFORMED STAPLES, STAPLE LINE MISSING STAPLES, ETC.)? NO. 2. HOW WAS THE BLEEDING CONTROLLED? NEW CLIP. 3. HOW MUCH BLOOD WAS LOST (ML)? UNSURE. 4. DID THE PATIENT REQUIRE A TRANSFUSION? NO. 5. COULD YOU PLEASE PROVIDE MORE DETAILS ABOUT THE TYPE OF OOZING? SMALL AMOUNTS. 1. DID DEVICE SIDEWAYS FEED CLIPS? YES. 2. DID DEVICE FIRE MALFORMED CLIPS? YES. 3. DID DEVICE FIRE SCISSORED CLIPS? YES. 4. DID THE CLIP NOT HOLD ON THE VESSEL OR TISSUE ONCE PLACED? YES. 5. WERE THERE ANY PATIENT CONSEQUENCES? MORE BLEEDING. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS WERE FOLDING OVER ONE ANOTHER, NOT STAYING ON STAPLE LINE, HAVING ISSUES RELOADING ONTO TRACK. THERE WAS NO PATIENT CONSEQUENCE REPORTED.