PREMIUM MULTIFIRE TA 010315-

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-12-10 for PREMIUM MULTIFIRE TA 010315- manufactured by Covidien Lp Llc North Haven.

Event Text Entries

[129775413] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[129775414] According to the reporter, during a left pneumonectomy procedure, the instrument remained closed on the vein. The tissue was dissected and another stapler was applied to be able to remove the device. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219930-2018-06572
MDR Report Key8146426
Report SourceFOREIGN,USER FACILITY
Date Received2018-12-10
Date of Report2018-12-10
Date of Event2018-11-15
Date Mfgr Received2018-11-15
Date Added to Maude2018-12-10
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 ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN LP LLC NORTH HAVEN
Manufacturer Street195 MCDERMOTT RD
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal Code06473
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePREMIUM MULTIFIRE TA
Generic NameAPPARATUS, SUTURING, STOMACH AND INTESTINAL
Product CodeFHM
Date Received2018-12-10
Returned To Mfg2019-01-21
Model Number010315-
Catalog Number010315-
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN LP LLC NORTH HAVEN
Manufacturer Address195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-10

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