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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 EGIA30CTAV
Medical Device Problem Code Failure to Cut (2587)
Health Effect - Clinical Codes No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event 06/19/2018
Type of Reportable Event Malfunction
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 lobectomy procedure, at the fourth firing, the surgeon clamped the vessel and fired the device and they could staple the vessel, however, they could not resect the vessel.Surgeon cut the vessel by scissors ad additionally sutured it by tread.The 5th firing to bronchus by the same handle was successful.There was no patient injury.
 
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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 Key7666562
Report Number1219930-2018-03657
Device Sequence Number1040624
Product Code GDW
UDI-Device Identifier10884521186101
UDI-Public10884521186101
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberEGIA30CTAV
Device Catalogue NumberEGIA30CTAV
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/21/2018
Initial Report FDA Received Date07/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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