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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 030450
Medical Device Problem Codes Failure to Fire (2610); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
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 partial gastrectomy, the stapler cannot press the green button and cannot squeeze the handle.The device did not fire.A black foreign object in the staple box was also noted.Replaced by a new device to complete the case.No 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 Key7846698
Report Number1219930-2018-04858
Device Sequence Number16639588
Product Code GDW
UDI-Device Identifier10884523002812
UDI-Public10884523002812
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K111825
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/05/2018
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 Expiration Date09/30/2019
Device Model Number030450
Device Catalogue Number030450
Device Lot NumberN4J1088KX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/17/2018
Initial Report FDA Received Date09/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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