MalfunctionFHO
PNEUMO-MATIC INSUFFLATION NEEDLE
Received Apr 14, 2017 · Event occurred Apr 13, 2017
Report MW5069149 · MDR key 6499884
Device
Generic name
Veress Needle
Manufacturer
Cooper SurgicalModel number
900-200Catalog number
900-200
Lot number
213729
Product problems
- Leak/Splash
Patient
57 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
COOPER SURGICAL, PNEUMO-MATIC INSUFFLATION NEEDLE HAS A LEAK, THAT WHEN OCCLUDED ON THE END OF THE NEEDLE (TESTED PRIOR TO USE) PREVENTS THE HIGH PRESSURE INSUFFLATION ALARM FROM ACTIVATING.