PNEUMO-MATIC INSUFFLATION NEEDLE 14 GAUGE 120MM 900-200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-27 for PNEUMO-MATIC INSUFFLATION NEEDLE 14 GAUGE 120MM 900-200 manufactured by Cooper Surgical.

Event Text Entries

[74074368] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5069388
• MDR Report Key: 6529513
• Date Received: 2017-04-27
• Date of Report: 2017-04-27
• Date of Event: 2017-04-26
• Date Added to Maude: 2017-04-28
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: PNEUMO-MATIC INSUFFLATION NEEDLE 14 GAUGE 120MM
• Generic Name: VERESS NEEDLE
• Product Code: FHO
• Date Received: 2017-04-27
• Model Number: 900-200
• Catalog Number: 900-200
• Lot Number: 213729
• Device Expiration Date: 2020-01-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOPER SURGICAL
• Manufacturer Address: TRUMBULL CT 06611 US 06611

Device Sequence Number: 2

• Brand Name: PNEUMO-MATIC INSUFFLATION NEEDLE 14 GAUGE 120MM
• Generic Name: VERESS NEEDLE
• Product Code: FHO
• Date Received: 2017-04-27
• Model Number: 900-200
• Catalog Number: 900-200
• Lot Number: 213729
• Device Expiration Date: 2020-01-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: COOPER SURGICAL
• Manufacturer Address: TRUMBULL CT 06611 US 06611

Device Sequence Number: 3

• Brand Name: PNEUMO-MATIC INSUFFLATION NEEDLE 14 GAUGE 120MM
• Generic Name: VERESS NEEDLE
• Product Code: FHO
• Date Received: 2017-04-27
• Model Number: 900-200
• Catalog Number: 900-200
• Lot Number: 213729
• Device Expiration Date: 2020-01-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: COOPER SURGICAL
• Manufacturer Address: TRUMBULL CT 06611 US 06611

Device Sequence Number: 4

• Brand Name: PNEUMO-MATIC INSUFFLATION NEEDLE 14 GAUGE 120MM
• Generic Name: VERESS NEEDLE
• Product Code: FHO
• Date Received: 2017-04-27
• Model Number: 900-200
• Catalog Number: 900-200
• Lot Number: 213729
• Device Expiration Date: 2020-01-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: COOPER SURGICAL
• Manufacturer Address: TRUMBULL CT 06611 US 06611

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-04-27