PREMIUM MF TA* 30-V3 TITANIUM STAPLER 010315

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-11 for PREMIUM MF TA* 30-V3 TITANIUM STAPLER 010315 manufactured by Covidien, Formerly Us Surgical A Divison.

Event Text Entries

[59754185] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[59754186] According to the reporter: during a thoracic procedure, the doctor attempted to fire the device on 2 occasions resulting in bleeding. Stapler deployment was incomplete, resulting in only partial ligation of the pulmonary vein. The doctor subsequently ligated the remainder of the pulmonary vein with prolene suture to achieve hemostasis. The patient was transferred to pacu in stable condition after surgery.
Patient Sequence No: 1, Text Type: D, B5


[63762575]
Patient Sequence No: 1, Text Type: N, H10


[68785845] (b)(4). Post market vigilance (pmv) led an evaluation of one premium mf ta 30-v3 titanium stapler and two premium mf ta 30-v3 titanium dlu. This evaluation was based on a medical and technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends and an evaluation of the returned device. The jaws were open. The sulus were fully fired; one sulu had two malformed staple. The sulus were reloaded with staples. The instrument and sulus were fired over test media with acceptable staple formation. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1219930-2016-01182
MDR Report Key6096464
Date Received2016-11-11
Date of Report2016-10-19
Date Mfgr Received2017-01-30
Device Manufacturer Date2014-06-01
Date Added to Maude2016-11-11
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 FDA3
Event Location3
Manufacturer ContactSHARON MURPHY
Manufacturer Street60 MIDDLETOWN AVENUE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925267
Manufacturer G1COVIDIEN, FORMERLY US SURGICAL A DIVISON
Manufacturer Street60 MIDDLETOWN AVE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal Code06473
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePREMIUM MF TA* 30-V3 TITANIUM STAPLER
Generic NameAPPARATUS, SUTURING, STOMACH AND INTESTINAL
Product CodeFHM
Date Received2016-11-11
Returned To Mfg2016-12-06
Model Number010315
Catalog Number010315
Lot NumberN4F0438X
Device Expiration Date2019-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN, FORMERLY US SURGICAL A DIVISON
Manufacturer Address60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-11-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.