MalfunctionGCB
RING
Received Nov 14, 2025 · Event occurred Aug 29, 2025
Report 23554332 · MDR key 23554332
Device
Generic name
Needle, Catheter
Manufacturer
Cook IncorporatedModel number
G03388Catalog 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.