MalfunctionFHO
PNEUMO MATIC INSUFFLATION NEEDLE
Received Aug 14, 2017 · Event occurred Aug 11, 2017
Report MW5071641 · MDR key 6800875
Device
Generic name
Insufflation Needle
Manufacturer
Cooper SurgicalModel number
900-210Catalog number
900-210
Lot number
186236
Product problems
- Failure to Advance
Patient
28 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
TWO (2) COOPER SURGICAL, PNEUMO-MATIC INSUFFLATION NEEDLES DID NOT PASS CO2 PRESSURE TEST WITH DR. (B)(6).