LIGAMAX

Additional Manufacturer Narrative

(B)(4). DATE SENT 7/7/2026. D4 BATCH # A98U0V. INVESTIGATION SUMMARY- THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE EL5ML DEVICE WAS RECEIVED WITH NO APPARENT EXTERNAL DAMAGE. IN AN ATTEMPT TO REPLICATE THE REPORTED EVENT, THE DEVICE WAS SUBJECTED TO FUNCTIONAL TESTING. DURING TESTING, THE DEVICE WAS FIRED; HOWEVER, THE CLIPS FAILED TO ADVANCE INTO THE JAWS. FURTHER EXAMINATION REVEALED THAT THE TIP OF THE ADVANCER WAS BENT. THE INSTRUMENT WAS SUBSEQUENTLY DISASSEMBLED FOR DETAILED EVALUATION. UPON DISASSEMBLY, THE ADVANCER DEFORMATION WAS CONFIRMED, AND EIGHT (8) CLIPS WERE IDENTIFIED WITHIN THE CLIP TRACK. THE EVENT IS RELATED TO IMPROPER USE OF THE DEVICE. PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE DEVICE SHAFT IS PAST THE END OF THE TROCAR CANNULA. EXCESSIVELY APPLYING A SIDE LOAD TO THE JAWS, CAUSING THEM TO PARTIALLY COLLAPSE, COULD RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE DEVICE. AS PART OF EES QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH A98U0V NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

Description of Event or Problem

IT WAS REPORTED THAT DURING LAPAROSCOPIC CHOLECYSTECTOMY, JAMMING OCCURRED FROM THE THIRD FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.