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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO TA; STAPLE, IMPLANTABLE
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US SURGICAL PUERTO RICO TA; STAPLE, IMPLANTABLE Back to Search Results
Model Number TA4535S
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Failure to Anastomose (1028)
Date of Event 04/26/2021
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, one month postoperative to open colorectal surgery, the patient had to undergo emergency surgery in another hospital because the staples were opened.
 
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Brand Name
TA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
MDR Report Key12018064
Report Number2647580-2021-02080
Device Sequence Number3426424
Product Code GDW
UDI-Device Identifier10884521043176
UDI-Public10884521043176
Combination Product (Y/N)N
Initial Reporter CountryPM
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/17/2021
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 Date11/30/2024
Device Model NumberTA4535S
Device Catalogue NumberTA4535S
Device Lot NumberP9M1503MY
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/26/2021
Initial Report FDA Received Date06/17/2021
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; Required Intervention;
Patient Age25 YR
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