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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN-MFG EEA; GUIDE, SURGICAL, INSTRUMENT
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COVIDIEN NORTH HAVEN-MFG EEA; GUIDE, SURGICAL, INSTRUMENT Back to Search Results
Model Number EEATAID25D
Medical Device Problem Code Failure to Align (2522)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/30/2017
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 gastric bypass procedure, the anvil tilted while surgeon was attempting to place in gastrotomy.The scrub nurse had difficulty getting the introducer to attach to the shaft.She stated that they used to click or pop into place, but as of late she feels it is not sticking into place.There was no patient injury.
 
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Brand Name
EEA
Common Device Name
GUIDE, SURGICAL, INSTRUMENT
Manufacturer (Section D)
COVIDIEN NORTH HAVEN-MFG
195 mcdermott rd
north haven CT 06473
MDR Report Key7127231
Report Number1219930-2017-10155
Device Sequence Number11094815
Product Code FZX
UDI-Device Identifier10884521045712
UDI-Public10884521045712
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 12/18/2017
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 Date08/31/2022
Device Model NumberEEATAID25D
Device Catalogue NumberEEATAID25D
Device Lot NumberK7H0004X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/30/2017
Initial Report FDA Received Date12/18/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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