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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE Back to Search Results
Model Number EGIATRS45AMT
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/20/2018
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, during laparoscopic gastroplasty, while on stomach - pouch, the doctor reported that even with the load-bearing film the clamp line bled.The doctor needed to oversew the clamp line to resolve the issue.
 
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Brand Name
ENDO GIA
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key8256321
Report Number1219930-2019-00345
Device Sequence Number16623223
Product Code GDW
UDI-Device Identifier10884521190887
UDI-Public10884521190887
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K133938
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/17/2019
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 Expiration Date11/30/2019
Device Model NumberEGIATRS45AMT
Device Catalogue NumberEGIATRS45AMT
Device Lot NumberN6L0520KRX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/20/2018
Initial Report FDA Received Date01/17/2019
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 Required Intervention;
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