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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 Codes Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes Tissue Damage (2104); No Code Available (3191)
Date of Event 05/07/2019
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 a total gastrectomy, in the esophagus, when mating the anvil to the trocar spike the anvil would not stay engaged and would disengage making it unable to fire.There was an unanticipated tissue loss and tissue damage as a result of this problem, the surgeon had to make an additional resection on the esophagus due to device issue.The case was extended 30 minutes to the product problem.Another stapler and anvil was used to complete the case.
 
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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 Key8649630
Report Number1219930-2019-03140
Device Sequence Number13985872
Product Code GDW
UDI-Device Identifier20884521042862
UDI-Public20884521042862
Combination Product (Y/N)N
Initial Reporter StateOH
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) 05/29/2019
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 NumberEEAORVIL25
Device Catalogue NumberEEAORVIL25
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/07/2019
Initial Report FDA Received Date05/29/2019
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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