MalfunctionGCJ
DETACHABLE ENDO POCKET
Received Jul 8, 2026 · Event occurred May 28, 2026
Report 3007791595-2026-00008 · MDR key 25744637
Device
Generic name
Detachable Endo Pocket
Manufacturer
Unimax Medical Systems Inc.Catalog number
SB534
Lot number
6252508145
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE SB534 UNRAVELED DURING THE PROCEDURE CAUSING THE GALL BLADDER AND BILE TO FALL INTO THE ABDOMINAL CAVITY. NO PATIENT/USER IMPACT.