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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 015485L
Medical Device Problem Code Failure to Form Staple (2579)
Health Effect - Clinical Codes Tissue Damage (2104); No Code Available (3191)
Date of Event 06/24/2020
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, during an open colorectal procedure, on stapler application, only half of the staple line fired.There was an unanticipated tissue loss and tissue damage.The surgeon tried make an anastomosis after the event but the patient required an ostomy bag to resolve the issue.The surgical time was extended by 30 minutes or more due to the product problem.
 
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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 Key10264820
Report Number2647580-2020-02131
Device Sequence Number972010
Product Code GDW
UDI-Device Identifier10884521047433
UDI-Public10884521047433
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K855047
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/13/2020
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 Expiration Date02/28/2023
Device Model Number015485L
Device Catalogue Number015485L
Device Lot NumberP8B0866X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/24/2020
Initial Report FDA Received Date07/13/2020
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 Required Intervention;
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