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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EDGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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COVIDIEN MFG DC BOULDER EDGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number E1455-4
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/15/2019
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 the lumpectomy, an electrode became loose and fell out of the pencil.It fell into the patient cavity but was retrieved by hand.Another electrode was opened and was used to complete the case.There was no patient injury.
 
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Brand Name
EDGE
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
MDR Report Key8316874
Report Number1717344-2019-00170
Device Sequence Number16390218
Product Code GEI
UDI-Device Identifier10884521713185
UDI-Public10884521713185
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K981916
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/07/2019
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 Expiration Date09/06/2023
Device Model NumberE1455-4
Device Catalogue NumberE1455-4
Device Lot Number82490171X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/15/2019
Initial Report FDA Received Date02/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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