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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 Loss of or Failure to Bond (1068)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 05/07/2020
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, during a laparoscopic esophagectomy procedure, the device did not fire.It was also reported that they had difficulty using the orvil but they were able to close it after a while.The surgical procedure was extended for more than 30 minutes due to using a suturing device to resolve the issue.
 
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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 Key10084325
Report Number1219930-2020-02125
Device Sequence Number3751992
Product Code GDW
UDI-Device Identifier20884521042862
UDI-Public20884521042862
Combination Product (Y/N)N
Initial Reporter CountryFI
PMA/510(K) Number
K062850
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/22/2020
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 NumberEEAORVIL25
Device Catalogue NumberEEAORVIL25
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/07/2020
Initial Report FDA Received Date05/22/2020
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;
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