MalfunctionFHO
PNEUMO-MATIC INSUFFLATION NEEDLE
Received Dec 18, 2019 · Event occurred Dec 5, 2019
Report MW5091759 · MDR key 9495952
Device
Generic name
Pneumoperitoneum Needle
Manufacturer
Cooper Surgical, Inc.Model number
900-200Catalog number
900-200
Lot number
265897
Product problems
- Difficult to Remove
Patient
72 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PORTION OF RED PLASTIC TIP PROTECTOR ON THE PNEUMO-MATIC INSUFFLATION, NEEDLE REMAINED IN THE INSUFFLATION TIP UPON REMOVAL OF THE TIP PROTECTOR. FDA SAFETY REPORT ID # (B)(4).