MalfunctionFZP

EPIX® UNIVERSAL CLIP APPLIER

Received Jul 7, 2026 · Event occurred Jun 12, 2026

Report 2027111-2026-00631 · MDR key 25737146

Device

Generic name

Clip, Implantable

Manufacturer

Applied Medical Resources

Model number

CA500

Catalog number

101474072

Lot number

1580888

Product problems

Failure to Fire

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

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.

Description of Event or Problem

PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: SURGEON USED A CLIP APPLIER TODAY DURING LAP CHOLE AND THE CLIP MISFIRED DURING THE CLIP APPLICATION. IT HAPPENED TWICE WITH THE SAME DEVICE. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 22JUN2026: CLIP MISFIRED DURING LOADING THE CLIP. CLIPS WOULDN¿T COME OUT WHEN THE HANDLE WAS PULLED BUT CAME OUT AFTER THE FACT. 2 CLIPS WERE DISPENSED IN TOTAL INTERVENTION: OPENED ANOTHER CLIP APPLIER. PATIENT STATUS: FINE.