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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO EEA; STAPLE, IMPLANTABLE Back to Search Results
Model Number TRIEEAXL28MT
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 07/14/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, 2 days post-operative, patient developed bleeding from the anus.Laparoscopic robotic sigmoidectomy went fine.Anastomosis was tested and there were no leaks.Tissue donuts were complete and thick.Case was completed without product concern.Patient hospitalization was extended by 1 more day.
 
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Brand Name
EEA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key12275572
Report Number2647580-2021-02598
Device Sequence Number3611830
Product Code GDW
UDI-Device Identifier10884521593121
UDI-Public10884521593121
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K172361
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date05/31/2025
Device Model NumberTRIEEAXL28MT
Device Catalogue NumberTRIEEAXL28MT
Device Lot NumberP0F0684Y
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/15/2021
Initial Report FDA Received Date08/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Other;
Patient Age52 YR
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