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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 Failure To Adhere Or Bond (1031); Positioning Problem (3009)
Health Effect - Clinical Code Death (1802)
Date of Event 06/05/2018
Type of Reportable Event Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during an exploratory laparotomy partial gastrectomy procedure, the orvil would not connect to the stapler.The device was difficult to load and was unable to close.To resolve the issue, they opened a new stapler and attached it to the same orvil.The patient was very sick and died later in the hospital.This was not related to the surgery.
 
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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 Key7646039
Report Number1219930-2018-03472
Device Sequence Number19220004
Product Code GDW
UDI-Device Identifier20884521042862
UDI-Public20884521042862
Combination Product (Y/N)N
Initial Reporter StatePA
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 Health Professional
Type of Report Initial
Report Date (Section B) 06/28/2018
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 06/07/2018
Initial Report FDA Received Date06/28/2018
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 Death;
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