MalfunctionPKL
Instinct
Received Jul 28, 2026 · Event occurred Jul 14, 2026
Report 50053114 · MDR key 50053114
Device
Generic name
Hemostatic Metal Clip For The Gi Tract
Manufacturer
Cook IncorporatedModel number
G58010Catalog number
INSC-P-7-230-S
Lot number
W5030291
Product problems
- Loose or Intermittent Connection
- Difficult to Open or Close
Patient
Male
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
Pt had rectal ulcer that was actively bleeding. Dr. advanced the cook medical hemoclip but as soon as it appeared in view, the clip loosened and was not opening. Instrument was able to removed and clip was intact and deployed outside of patient.