LIGAMAX

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IT WASN´T POSSIBLE TO FIRING THE DEVICE. NO PATIENT OUTCOME.

Additional Manufacturer Narrative

(B)(4). DATE SENT 7/7/2026. D4 BATCH # A99A20. 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. ADDITIONALLY, THE OPENED PACKAGING WAS RETURNED TOGETHER WITH THE INSTRUMENT. TO ATTEMPT TO REPLICATE THE REPORTED ISSUE, THE DEVICE WAS SUBJECTED TO FUNCTIONAL TESTING. UPON FIRING, THE CLIPS DID NOT ADVANCE INTO THE JAW AS INTENDED. FURTHER INSPECTION REVEALED THAT THE ADVANCER TIP WAS BENT. THE DEVICE WAS SUBSEQUENTLY DISASSEMBLED, AND THE DEFORMATION OF THE ADVANCER WAS CONFIRMED. DURING DISASSEMBLY, FIVE (5) CLIPS WERE IDENTIFIED WITHIN THE CLIP TRACK. THE EVENT REPORTED WAS CONFIRMED AND 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 A99A20 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.