LIGAMAX

Additional Manufacturer Narrative

(B)(4) DATE SENT: 6/25/2026 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: WHAT WAS INITIAL PROCEDURE? LAPAROSCOPIC CHOLECYSTECTOMY HOW WAS THE LEAK DISCOVERED OR DIAGNOSED (WHAT TESTS, SCANS, ETC. WERE PERFORMED)? POST OP HIDA SCAN. IF REOPERATION, WHAT WAS FOUND AT REOPERATION? THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR ERCP AND STENT SO I HAVE NO FURTHER UPDATE ON CARE OR CONDITION. HOW WAS PATIENT TREATED FOR THE LEAK THAT OCCURRED? ERCP AND STENT WHAT IS CURRENT PATIENT STATUS? SEE ABOVE WHAT TYPE OF PROCEDURE WAS BEING PERFORMED? LAP CHOLE AS ABOVE WHICH FIRING DID THE INCIDENT OCCUR ON? ALL OF THEM WAS THERE ANY FEEDING ISSUES EXPERIENCED WITH THE DEVICE? I¿M NOT AWARE OF ANY WERE THE CLIPS VISUALIZED ANY OTHER WAY OTHER THAN THE POST OP IMAGE TO CONFIRM THAT THEY WERE COMPRESSED? YES, THEY LOOKED NORMALLY COMPRESSED VISUALLY AT THIS DESCRIPTION IS NOT ACCURATE. THERE WERE 3 CLIPS PLACED ON THE CYSTIC DUCT AT SURGERY, ALL PERFECTLY PARALLEL TO EACH OTHER, WELL ACROSS THE VERY THIN DIAMETER OF THE CYSTIC DUCT, AND WITH THE INSTRUMENT TRIGGER SQUEEZED ALL THE WAY TO THE HANDLE. I HAVE BEEN DOING THESE SURGERIES FOR (PLEASE REFER TO THE ATTACHED MAIL), NOT 5. AND ON POST OP IMAGING ONLY 2 CLIPS ARE SEEN INDICATING ONE DEFINITELY CAME OFF. THUS, THE BILE LEAK WAS THROUGH TWO CLIPS REMAINING ON THE CYSTIC DUCT AND BOTH APPEAR FULLY COMPRESSED ON THE POST OP IMAGING. IT SEEMS IMPOSSIBLE TO BELIEVE, AFTER SUCCESSFULLY PLACING THESE CLIPS FOR DECADES, THAT THE INSTRUMENT WAS SUDDENLY NOT USED PROPERLY, AND TAKEN TOGETHER WITH THE ABOVE, I AM RAISING THE QUESTION OF WHETHER THE CLIP APPLIER DID NOT FUNCTION PROPERLY. 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

SURGEON REQUESTING INFORMATION REGARDING A CLIP APPLIER. HE REPORTED A RECENT PATIENT SURGERY, INVOLVING A GALLBLADDER REMOVAL. POST-PROCEDURE, THERE WAS BILE LEAKAGE PAST THE CLIP AT THE CYSTIC DUCT, WHICH HE INDICATED MAY HAVE BEEN DUE TO ONE CLIP DETACHING.