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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN EEA ORVIL; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN EEA ORVIL; STAPLE, IMPLANTABLE Back to Search Results
Model Number EEAORVIL25
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
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, the patient was fine after the initial operation of esophagectomy but eventually developed bleeding.The surgeon said that the devices worked as intended during the initial procedure nearly a year ago.The anastomosis was created, a leak test was performed and the case was completed, but the issue arose post operatively as the patient did not do well and had recurrent bleeding at the anastomotic site.The patient was readmitted to control the active bleeding and underwent an angiogram twice.
 
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Brand Name
EEA ORVIL
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key7794368
Report Number1219930-2018-04569
Device Sequence Number19155090
Product Code GDW
UDI-Device Identifier20884521042862
UDI-Public20884521042862
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K062850
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) 08/17/2018
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 NumberEEAORVIL25
Device Catalogue NumberEEAORVIL25
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/02/2018
Initial Report FDA Received Date08/17/2018
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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