MalfunctionFHO
PNEUMO-MATIC INSUFFLATION NEEDLE
Received Oct 23, 2020 · Event occurred Oct 21, 2020
Report MW5097438 · MDR key 10733247
Device
Generic name
Pneumoperitoneum Needle
Manufacturer
Coopersurgical, Inc.Model number
900-200Catalog number
900-200
Lot number
277793
Product problems
- Device Markings/Labelling Problem
- Pressure Problem
Patient
46 YR
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
A TOTAL OF (3) INSUFFLATION NEEDLES DID NOT PASS A HIGH PRESSURE EVALUATION BY THE SURGEON PRIOR TO THEIR USE. A TOTAL OF (3) DEVICES IDENTIFIED. TWO WITH EXPIRATION DATE 4/17/2023, AND ONE WITH AN EXPIRATION DATE OF 6/16/2023. FDA SAFETY REPORT ID # (B)(4).