PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH PN120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2009-07-27 for PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH PN120 manufactured by Ethicon Endo-surgery, Llc.

Event Text Entries

[15557161] It was reported that during a liver biopsy procedure, there was an air leak. Another device was used to complete the case. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


[15891778] (b) (4). (b) (4). Information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005075853-2009-04381
MDR Report Key1484666
Report Source01,05,06,07
Date Received2009-07-27
Date of Report2009-07-01
Date of Event2009-06-29
Date Mfgr Received2009-06-30
Date Added to Maude2010-05-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactKATHY RICE
Manufacturer Street4545 CREEK RD
Manufacturer CityCINCINNATI OH 452422803
Manufacturer CountryUS
Manufacturer Postal452422803
Manufacturer Phone5133373299
Manufacturer G1ETHICON ENDO-SURGERY, LLC
Manufacturer Street475 CALLE C
Manufacturer CityGUAYNABO PR 00969
Manufacturer CountryUS
Manufacturer Postal Code00969
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NamePNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH
Product CodeFDP
Date Received2009-07-27
Model NumberNA
Catalog NumberPN120
Lot NumberF4MZ2V
ID NumberBATCH # 18478
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerETHICON ENDO-SURGERY, LLC
Manufacturer AddressGUAYNABO PR US


Patients

Patient NumberTreatmentOutcomeDate
10 2009-07-27

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