MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCE TRIVERSE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	FT3000
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
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, during nephrectomy, the electrode tip caught fire like a match and the fire was put out to continue the procedure.The electrode tip was covered with insulation tube during use.The generator setting was 30w most of the time.The surgeon's glove burnt but there was no injury.Also no patient harm.No further information available at this time.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.The electrode tip was covered with insulation tube during use.The reported condition was not confirmed.The investigation found the electrode and pencil both past hipot testing.The electrode had a piece of tubing over most of the electrode.The investigation found the device to function normally and within specifications.The instruction for use states, do not modify or add to the insulation of active electrodes.If insulated electrodes are required, use an appropriate insulated electrode.If information is provided in the future, a supplemental report will be issued.

• 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 Key: 7650272
• Report Number: 1717344-2018-00876
• Device Sequence Number: 2044302
• Product Code: GEI
• UDI-Device Identifier: 20884524000081
• UDI-Public: 20884524000081
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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 Expiration Date: 04/23/2023
• Device Model Number: FT3000
• Device Catalogue Number: FT3000
• Device Lot Number: 81140148X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1