MalfunctionNWV

EPIX LAPAROSCOPIC GRASPER

Received May 1, 2026 · Event occurred Apr 2, 2026

Report 2027111-2026-00538 · MDR key 25062232

Device

Generic name

Laparoscopic Accessories, Gynecologic

Manufacturer

Applied Medical Resources

Model number

C4130

Catalog number

Lot number

Product problems

Material Fragmentation

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 PROVIDED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

PROCEDURE PERFORMED: LAP CHOL EVENT DESCRIPTION: THE DEVICE WAS BEING USED DURING PULLING TISSUE. PULLING AWAY TISSUE WITH FORCE THE JAW BROKE OFF. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 09APR26: THE JAWS FULLY DETACHED AND ALL THE MATERIALS WERE RETRIEVED FROM THE PATIENT. NO INFORMATION ON THE FOLLOWING, WHAT WAS THE SURGEON GRASPING WHEN THE BREAKAGE OCCURRED. INTERVENTION: DEVICE REPLACEMENT PATIENT STATUS: PATIENT IS OK.