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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TA; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN TA; STAPLE, IMPLANTABLE Back to Search Results
Model Number TA9048L
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Failure to Anastomose (1028); No Code Available (3191)
Date of Event 05/26/2020
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, post-operatively a colectomy procedure, the patient returned to the operating room and a second surgery repair due to anastomosis leak.The surgical procedure was extended for more than 30 minutes and manual suturing was done to resolve the issue.
 
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Brand Name
TA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key10355385
Report Number1219930-2020-03115
Device Sequence Number951549
Product Code GDW
UDI-Device Identifier20884521043265
UDI-Public20884521043265
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K111825
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) 08/03/2020
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 Model NumberTA9048L
Device Catalogue NumberTA9048L
Device Lot NumberP5G0693X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/16/2020
Initial Report FDA Received Date08/03/2020
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;
Patient Age66 YR
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