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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 EGIARADXT
Medical Device Problem Codes Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/18/2020
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 rectosigmoidectomy procedure, after positioning and closing the load a trigger has been taken, at this instant hearing a strong snap that believes to be of the load and presence of open clamps.There was the need to change the load 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 Key9792612
Report Number1219930-2020-01031
Device Sequence Number3331903
Product Code GDW
UDI-Device Identifier10884521141742
UDI-Public10884521141742
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K102291
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) 03/05/2020
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 Expiration Date03/31/2020
Device Model NumberEGIARADXT
Device Catalogue NumberEGIARADXT
Device Lot NumberN5C0648X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/19/2020
Initial Report FDA Received Date03/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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