inforMED
MalfunctionGCB

RING

Received Nov 14, 2025 · Event occurred Aug 29, 2025

Report 23554332 · MDR key 23554332

Device

Generic name

Needle, Catheter

Manufacturer

Cook Incorporated

Model number

G03388

Catalog number

DLPN-40-25-RING

Lot number

15247453

Product problems

  • Detachment of Device or Device Component

Patient

NA · Female

  • Abscess
  • Abscess

Narrative

Description of Event or Problem

PATIENT WAS SEEN IN THE OFFICE FOR VAGINAL DRAINAGE, AND ON EXAMINATION THERE WAS CONCERN FOR A FOREIGN BODY. PATIENT WAS TAKEN TO THE OPERATION ROOM FOR EXAM UNDER ANESTHESIA. VAGINAL CUFF ABSCESS/SEPARATION WAS NOTED, AND WITHIN IT A SMALL PORTION (1-2CM) OF AN IR [INTERVENTIONAL RADIOLOGY] DRAIN WAS NOTED. THIS WAS EASILY REMOVED AND SENT TO PATHOLOGY FOR CONFIRMATION. PATIENT REQUIRED A LAPAROSCOPY AND VAGINAL CUFF REPAIR, WITHOUT LONG-TERM CONSEQUENCES EXPECTED.