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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE Back to Search Results
Model Number SIGC45VM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event 04/07/2021
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 an open lung transplantation, there was a big leakage and bleeding in the pulmonary artery and pulmonary vein after firing the stapler cartridge.The surgeon had sutured and ligatured the pulmonary artery and vein to resolve the issue.
 
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Brand Name
TRI-STAPLE 2.0
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key11736006
Report Number1219930-2021-01661
Device Sequence Number3104782
Product Code GDW
UDI-Device Identifier10884521543553
UDI-Public10884521543553
Combination Product (Y/N)N
Initial Reporter CountryTU
PMA/510(K) Number
K160176
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/28/2021
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 Date06/30/2023
Device Model NumberSIGC45VM
Device Catalogue NumberSIGC45VM
Device Lot NumberN8F1007X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/08/2021
Initial Report FDA Received Date04/28/2021
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;
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