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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 EGIATRS45AXT
Medical Device Problem Code Failure to Fire (2610)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/11/2019
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 gastroplasty procedure, the 3 reloads were stuck.The surgeon was able to press the green button, the stapling could not be performed.The surgical time was extended by more than 30 minutes as it took time to get another load to change.New load was used 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 Key8751051
Report Number1219930-2019-03869
Device Sequence Number11244139
Product Code GDW
UDI-Device Identifier10884521190993
UDI-Public10884521190993
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K133938
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) 07/01/2019
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 Expiration Date07/31/2021
Device Model NumberEGIATRS45AXT
Device Catalogue NumberEGIATRS45AXT
Device Lot NumberN8G0212KX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/12/2019
Initial Report FDA Received Date07/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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