ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD EGIATRS60AMT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-11 for ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD EGIATRS60AMT manufactured by Covidien, Formerly Us Surgical A Divison.

Event Text Entries

[64492871] (b)(4). Initial reporter phone number: (b)(6). Contact office phone number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[64492874] According to the reporter, after a sleeve gastrectomy the surgeon mentioned that he feels that the stiffness of staple lines created with trs is causing an increase in reflux in some of his patients.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219930-2017-00044
MDR Report Key6241316
Report SourceUSER FACILITY
Date Received2017-01-11
Date of Report2016-12-14
Date Mfgr Received2016-12-14
Date Added to Maude2017-01-11
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 AVE
Manufacturer CityNORTH HAVEN
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 NameENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD
Generic NameMESH, SURGICAL, DEPLOYER
Product CodeORQ
Date Received2017-01-11
Model NumberEGIATRS60AMT
Catalog NumberEGIATRS60AMT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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. Other 2017-01-11

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