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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 EGIAADAPTXL
Medical Device Problem Codes Failure to Fire (2610); Human-Device Interface Problem (2949)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/24/2019
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 a laparoscopic sleeve gastrectomy, it was applied on the antrum side, the reload was not getting unloaded from the adapter, the stapler was not able to fire.The jaws of the device locked on the tissue and was removed by pulling back with the help of a grasper.The powered stapler was replaced with a manual stapler to complete the case.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 Key9554918
Report Number1219930-2020-00163
Device Sequence Number2019446
Product Code GDW
UDI-Device Identifier10884521201989
UDI-Public10884521201989
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K133762
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) 01/06/2020
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 NumberEGIAADAPTXL
Device Catalogue NumberEGIAADAPTXL
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/24/2019
Initial Report FDA Received Date01/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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