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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 SIGC60VT
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Blood Loss (2597); No Code Available (3191)
Date of Event 12/02/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).(surgical intervention).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, post operative a gastric bypass procedure, there was staple line bleeding.Patient lost a total of 1,750cc of blood that required blood transfusion.Due to the post-operative event, the patient had extended hospitalization of 3 days.
 
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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 Key9530225
Report Number1219930-2019-07235
Device Sequence Number19426902
Product Code GDW
UDI-Device Identifier10884521543522
UDI-Public10884521543522
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K163098
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/30/2019
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 Model NumberSIGC60VT
Device Catalogue NumberSIGC60VT
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/13/2019
Initial Report FDA Received Date12/30/2019
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 Hospitalization; Required Intervention;
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