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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 EEAXL2835
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Tissue Damage (2104); No Code Available (3191)
Date of Event 04/19/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, two days following a laparoscopic low anterior resection, the patient became sick and had to go back for additional surgery.The patient was given stoma.There was an unanticipated tissue loss and tissue damage.The patient had an extended hospitalization.The patient's post stoma has not been booked yet.
 
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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 Key8614011
Report Number2647580-2019-02567
Device Sequence Number11268137
Product Code GDW
UDI-Device Identifier10884523006148
UDI-Public10884523006148
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K062850
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/15/2019
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 Model NumberEEAXL2835
Device Catalogue NumberEEAXL2835
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/24/2019
Initial Report FDA Received Date05/15/2019
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; Required Intervention;
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