LIGACLIP

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

Additional Manufacturer Narrative

(B)(4). DATE SENT 7/6/2026. D4 BATCH # A70028. 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 REVEALED THAT THE ER320 DEVICE WAS RETURNED WITH THE JAWS CLOSED AND WITH NO APPARENT DAMAGE. IN ADDITION, THE PACKAGING OPENED WAS RETURNED ALONG WITH THE INSTRUMENT. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS ACTIVATED AND IT INTERMITTENTLY FED AND FORMED ELEVEN (11) CONFORMAL CLIPS. THE DEVICE WAS DISASSEMBLED TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS AND THE TRIGGER WAS FOUND BENT, CAUSING THE FEEDING ISSUES REPORTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH A70028 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. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.