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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 E2350HGNSB
Medical Device Problem Code Fire (1245)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/30/2018
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, a male was presented for a left kidney transplant.A flame was observed at the tip of the pen during the onset of the procedure.The device was not in contact with the patient at the time the flame occurred and was extinguished within seconds.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 Key7846573
Report Number1717344-2018-01170
Device Sequence Number1053043
Product Code GEI
UDI-Device Identifier00643169335011
UDI-Public00643169335011
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K962044
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other,use
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 09/05/2018
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 NumberE2350HGNSB
Device Catalogue NumberE2350HGNSB
Device Lot Number828618
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/16/2018
Initial Report FDA Received Date09/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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