EPIX LAPAROSCOPIC GRASPER
Received Mar 10, 2026 · Event occurred Feb 12, 2026
Report 2027111-2026-00430 · MDR key 24565141
Device
Generic name
Laparoscopic Accessories, Gynecologic
Manufacturer
Applied Medical ResourcesModel number
C4130Catalog number
101476261
Lot number
1560534
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PROCEDURE PERFORMED: LAPAROSCOPIC HYSTERECTOMY + BSO + D+C + PROCEED TO COLORECTAL ASSIST. EVENT DESCRIPTION: GRASPING/MANIPULATING TISSUE. NURSE STATED THAT THEY DIDN'T NOTICE THE PADDING HAD DETACHED FROM THE GRASPER UNTIL INSPECTION. IN DOING SO THEY NOTICED THE LATIS MESH WAS STILL INTACT HOWEVER THE PADDING WAS NOT AND NEEDED TO BE RETRIEVED FROM INSIDE THE PATIENT. THIS WAS LOCATED AFTER SOME TIME. NO CLINICAL IMPACT. INTERVENTION: COLORECTAL SURGEON WAS USING TWO ATRACS SO CONTINUED USING THE SECOND ONE AND AN ALTERNATIVE REUSABLE GRASPER FROM THE LAP TRAY. PATIENT STATUS: STABLE.
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.