MalfunctionFHO
PNEUMO-MATIC INSUFFLATION NEEDLE 14 GAUGE 120MM
Received Apr 27, 2017 · Event occurred Apr 26, 2017
Report MW5069388 · MDR key 6529513
Device
Generic name
Veress Needle
Manufacturer
Cooper SurgicalModel number
900-200Catalog number
900-200
Lot number
213729
Product problems
- Leak/Splash
- Device Operates Differently Than Expected
- Pressure Problem
Patient
51 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 NEEDLES (4) FROM THE SAME LOT # 213729, DID NOT PASS LEAK/HIGH PRESSURE ALARM TEST. A DIFFERENT STYLE OF VERESS NEEDLE WAS THEN TESTED, PASSED, AND UTILIZED FOR THE PROCEDURE WITHOUT INCIDENT. DATES OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.