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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO TA PREMIUM; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO TA PREMIUM; STAPLE, IMPLANTABLE Back to Search Results
Model Number 015458L
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/13/2018
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, following an open low anterior resection, a small bleeding was noticed.It was unsure if the bleeding was from the staple line.They wanted to check someone else had same problem with the same reload and same lot number.Drainage was done to resolve the issue.
 
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Brand Name
TA PREMIUM
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key8231395
Report Number2647580-2019-00184
Device Sequence Number215344
Product Code GDW
UDI-Device Identifier10884521047402
UDI-Public10884521047402
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K855047
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/09/2019
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 Expiration Date11/30/2022
Device Model Number015458L
Device Catalogue Number015458L
Device Lot NumberP7L1105X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/13/2018
Initial Report FDA Received Date01/09/2019
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 Required Intervention;
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