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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCE TRIVERSE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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COVIDIEN MFG DC BOULDER FORCE TRIVERSE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number FT3000
Medical Device Problem Codes Arcing (2583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/01/2020
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 a procedure, a lead was being tested when there was a flame that started in the pocket when the device was being used.It was also noted that there was an arc created.There was no patient injury.
 
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Brand Name
FORCE TRIVERSE
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
MDR Report Key10745863
Report Number1717344-2020-01304
Device Sequence Number19274454
Product Code GEI
UDI-Device Identifier10884524000084
UDI-Public10884524000084
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K051627
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/28/2020
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 Model NumberFT3000
Device Catalogue NumberFT3000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/09/2020
Initial Report FDA Received Date10/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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