LIGACLIP

Additional Manufacturer Narrative

(B)(4). DATE SENT 7/7/2026. D4 BATCH # Z70423 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 CONFIRMED THAT THE DEVICE WAS RETURNED WITH NO APPARENT DAMAGE, ALONG WITH THE OPENED PACKAGING. DURING FUNCTIONAL TESTING, THE TRIGGER COULD NOT BE ACTIVATED BECAUSE IT WAS JAMMED. THE DEVICE WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS, AND THE TRIGGER WAS FOUND BENT, PREVENTING CLIP ADVANCEMENT INTO THE JAWS. ADDITIONALLY, THIRTEEN (13) CLIPS REMAINED INSIDE THE CLIP TRACK. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH Z70423 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF EES QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. ADDITIONAL EVENT INFORMATION -THE JAW WAS OPEN, BUT IT FELT LIKE IT WAS STUCK TO THE CLIP AND WOULDN'T REMOVE. -THE DISSECTED SURROUNDING TISSUE WAS ORIGINALLY PART OF THE TISSUE BEING COLLECTED SIDE, SO THERE WAS NO IMPACT ON THE PATIENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ALTHOUGH THERE WAS AN UNUSUAL SENSATION FROM THE FIRST LOADING, CLIPPING COULD BE DONE THROUGH THE SECOND FIRING. DURING THE THIRD CLIPPING ATTEMPT, THE CLIP DID NOT DETACH FROM THE DEVICE, AND THE DEVICE COULD NOT BE REMOVED FROM THE ABDOMINAL CAVITY. THE DEVICE WAS REMOVED EXTRACORPOREALLY AFTER CUTTING THE SURROUNDING TISSUE. THE BLOOD VESSEL HAD BEEN CLIPPED WITHOUT ANY ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.