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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 EGIAADAPT
Medical Device Problem Code Entrapment of Device (1212)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/18/2019
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, when the device was being applied to the stomach during a robotic laparoscopic gastroplasty, the stapler was able to fire but there was a staple formation issue.It was also stated that the jaws of the device locked on tissue.The doctor needed to force the device to loosen the tissue.It was confirmed that two reloads had the same malfunction.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 Key9551151
Report Number1219930-2020-00131
Device Sequence Number19321115
Product Code GDW
UDI-Device Identifier10884521142800
UDI-Public10884521142800
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K121510
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/05/2020
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 NumberEGIAADAPT
Device Catalogue NumberEGIAADAPT
Device Lot NumberC2017E403
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/26/2019
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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