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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 TA4548L
Medical Device Problem Code Failure to Fire (2610)
Health Effect - Clinical Code Failure to Anastomose (1028)
Date of Event 03/21/2021
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, during open low anterior resection, upon anastomosis of intestine, when surgeon has fired the staplers, staple pins did not fired.Surgery has extended for almost 3 hours as product failed in first step of anastomosis and unanticipated tissue loss was noted.Surgeon complete surgery by using sutures.
 
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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 Key11652744
Report Number2647580-2021-01281
Device Sequence Number3396890
Product Code GDW
UDI-Device Identifier10884521043183
UDI-Public10884521043183
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/12/2021
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 NumberTA4548L
Device Catalogue NumberTA4548L
Device Lot NumberP9M1370MY
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/21/2021
Initial Report FDA Received Date04/12/2021
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 Required Intervention;
Patient Age40 YR
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