MalfunctionGCJ

INTEGRA® JARIT®

Received Apr 7, 2026 · Event occurred Mar 2, 2026

Report 24799480 · MDR key 24799480

Device

Generic name

Laparoscope, General Plastic Surgery

Manufacturer

Integra Lifesciences Production Corporation

Model number

505230

Catalog number

505-230

Lot number

Patient

34 YR · Female

Foreign Body In Patient

Narrative

Description of Event or Problem

THE INSTRUMENT WAS FOUND TO BE FUNCTIONAL; HOWEVER, PROPER ENGAGEMENT OF THE CONE TIP REQUIRES A 180-DEGREE TWIST FOR SECURE PLACEMENT. NO ONE NOTICED CONE MISSING FROM DEVICE UPON REMOVAL FROM USE. NO INJURY TO PATIENT, CONE PASSED SPONTANEOUSLY THROUGH VAGINA WHILE URINATING.