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 NumberMW5069388
MDR Report Key6529513
Date Received2017-04-27
Date of Report2017-04-27
Date of Event2017-04-26
Date Added to Maude2017-04-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NamePNEUMO-MATIC INSUFFLATION NEEDLE 14 GAUGE 120MM
Generic NameVERESS NEEDLE
Product CodeFHO
Date Received2017-04-27
Model Number900-200
Catalog Number900-200
Lot Number213729
Device Expiration Date2020-01-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCOOPER SURGICAL
Manufacturer AddressTRUMBULL CT 06611 US 06611

Device Sequence Number: 2

Brand NamePNEUMO-MATIC INSUFFLATION NEEDLE 14 GAUGE 120MM
Generic NameVERESS NEEDLE
Product CodeFHO
Date Received2017-04-27
Model Number900-200
Catalog Number900-200
Lot Number213729
Device Expiration Date2020-01-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerCOOPER SURGICAL
Manufacturer AddressTRUMBULL CT 06611 US 06611

Device Sequence Number: 3

Brand NamePNEUMO-MATIC INSUFFLATION NEEDLE 14 GAUGE 120MM
Generic NameVERESS NEEDLE
Product CodeFHO
Date Received2017-04-27
Model Number900-200
Catalog Number900-200
Lot Number213729
Device Expiration Date2020-01-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerCOOPER SURGICAL
Manufacturer AddressTRUMBULL CT 06611 US 06611

Device Sequence Number: 4

Brand NamePNEUMO-MATIC INSUFFLATION NEEDLE 14 GAUGE 120MM
Generic NameVERESS NEEDLE
Product CodeFHO
Date Received2017-04-27
Model Number900-200
Catalog Number900-200
Lot Number213729
Device Expiration Date2020-01-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No4
Device Event Key0
ManufacturerCOOPER SURGICAL
Manufacturer AddressTRUMBULL CT 06611 US 06611


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-27

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