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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 EEAXL2135
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Tissue Damage (2104); Blood Loss (2597); No Code Available (3191)
Date of Event 09/15/2020
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, postoperative from laparoscopic roux en y gastric bypass, while patient was in the post-anesthesia care unit, gastrointestinal bleeding (500 cc or more) was observed.The patient was transferred to another facility for a higher level of care.There was tissue damage.Blood transfusion had to be performed and hospitalization was extended by 2-3 days as a result of the event.
 
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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 Key10741028
Report Number2647580-2020-03472
Device Sequence Number3125703
Product Code GDW
UDI-Device Identifier10884523005585
UDI-Public10884523005585
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K062850
Number of Events Summarized1
Summary Report (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) 10/27/2020
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 NumberEEAXL2135
Device Catalogue NumberEEAXL2135
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/08/2020
Initial Report FDA Received Date10/27/2020
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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