MalfunctionFHO
PNEUMO-MATIC INSUFFLATION NEEDLE
Received Mar 30, 2017 · Event occurred Mar 29, 2017
Report MW5068795 · MDR key 6450597
Device
Generic name
Pneumoperitoneum Needle
Manufacturer
Cooper SurgicalModel number
900-200Catalog number
900-200
Lot number
208315
Product problems
- Leak/Splash
Patient
60 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
FOUR COOPER SURGICAL PNEUMO-MATIC INSUFFLATION NEEDLES WERE OPENED AND TESTED WITH LEAKS DISCOVERED IN THE UNIT'S INTEGRITY. SURGEON TESTS NEEDLE BY OCCLUSION PRIOR TO UTILIZING NEEDLE. DATES OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC HYSTERECTOMY.