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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 030452
Medical Device Problem Code Failure to Fire (2610)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/18/2020
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 laparoscopic colectomy procedure, after the device was assembled, the surgeon press the green button to enter the firing mode, and upon firing the device could not be fired.The surgeon then used another device reload to resolve the issue in order 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 Key10246351
Report Number1219930-2020-02704
Device Sequence Number573448
Product Code GDW
UDI-Device Identifier10884523002836
UDI-Public10884523002836
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,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/08/2020
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 Expiration Date07/02/2024
Device Model Number030452
Device Catalogue Number030452
Device Lot NumberT9G027X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/22/2020
Initial Report FDA Received Date07/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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