EPIX® UNIVERSAL CLIP APPLIER

Description of Event or Problem

PROCEDURE PERFORMED: CHOLECYSTECTOMY. EVENT DESCRIPTION: THE CLIP DOESN'T RELEASE. OR THE CLIP RELEASES BUT ISN'T TIGHT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON (B)(6) 2026: PATIENT IS GOOD. IT RELEASES BUT IS NOT PROPERLY SECURED, OR SOMETIMES IT DOES NOT RELEASE. SOMETIMES IT CLOSES BUT REMAINS STUCK IN THE JAWS. THE CLIP APPLIED ON CYSTIC DUCT AND CYSTIC ARTERY. THE CLIP WAS SEATED FULLY INTO THE JAWS UPON ACTUATION. THE SURGEON FULLY SKELETONIZED THE VESSEL BEFORE USING THE CLIP APPLIER. CLIP WAS LOADED INTO THE JAWS. 5MM TROCAR WAS USED. THE INCIDENT WAS OBSERVED DURING THE INSERTION OF THE FIRST CLIP OR A SUBSEQUENT CLIP. IT HAPPENED AGAIN AT LEAST 3 TIMES. IT APPEARED THE CLIP WAS LOADED AND VISIBLE BETWEEN THE DEVICE JAWS, WAS IT POSITIONED CORRECTLY. NO ACTUATION PERFORMED BY FULLY SQUEEZING THE TRIGGER ("PLASTIC-TO-PLASTIC") AND ALLOWING THE INSTRUMENT TO RESET. A LOADED CLIP WAS MANUALLY REMOVED FROM THE JAWS. THE DEVICE WAS ACTUATED AND THEN RESET. THE CLIP WAS MANUALLY REMOVED FROM THE JAWS. TRIGGER WAS EASY TO OPERATE AND FULLY FUNCTIONAL. INTERVENTION: CHANGED THE MEDICAL DEVICE. PATIENT STATUS: PATIENT IS GOOD.

Additional Manufacturer Narrative

THE EVENT DEVICE IS ANTICIPATED TO RETURN TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.