EEA EEA28

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for EEA EEA28 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[186106797] (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186106798] According to the reporter, following a rectal anastomoses, after the gun was fired on a laparoscopic sigmoid colectomy procedure, the stapler was stuck and was difficult to be removed from the cavity. The stapler was removed by hand manually but the anvil was left inside and a formation of ileostomy was carried out to prevent any further complications. The head of the anvil was pushed from the top and was grabbed with a babcock and pulled out. The two doughnuts were okay but the rectal one was thin but intact. The patient was discharged with no problem and will have watersolube enema to check the anastomosis in 2-3 weeks.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2647580-2020-01155
MDR Report Key9908197
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-06
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-03-25
Date Added to Maude2020-03-31
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 G1US SURGICAL PUERTO RICO
Manufacturer Street201 SABANETAS INDUSTRIAL PARK
Manufacturer CityPONCE PR 007164401
Manufacturer CountryUS
Manufacturer Postal Code007164401
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEEA
Generic NameSTAPLE, IMPLANTABLE
Product CodeGDW
Date Received2020-03-31
Returned To Mfg2020-03-20
Model NumberEEA28
Catalog NumberEEA28
Lot NumberP9C1603KY
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerUS SURGICAL PUERTO RICO
Manufacturer Address201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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