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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 Codes Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/20/2019
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 laparo appendectomy, at the first firing, after setting up the handle, it was checked that the three green lamps were illuminated without any problems, when it was attempted to fire the reload, the product was unable to fire.Furthermore, the status lamp illumination also had been checked before firing.The handle was able to fire and nothing was not clamped.The procedure was completed with another device.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 Key9442912
Report Number1219930-2019-06816
Device Sequence Number2243031
Product Code GDW
UDI-Device Identifier10884521142800
UDI-Public10884521142800
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K121510
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/10/2019
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 Model NumberEGIAADAPT
Device Catalogue NumberEGIAADAPT
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/21/2019
Initial Report FDA Received Date12/10/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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