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

Model Number	FT3000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open total abdominal hysterectomy, while performing hemostasis of the peritoneal and muscular layers.The gauze near the body sparked and had smoldering combustion.When fire was smoldering at the operation field, gauze was immediately removed and dropped on the floor, and fire was put out.It could not be specified how big the fire was.An isozine, a disinfectant, was found to be adhered to the gauze.Ft3000 was replaced and same ft10 was used.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d10, g4, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was returned for evaluation.It was reported that there was an operating room fire.An associated device issue could not be confirmed.Visual inspection and testing found no potentially contributing factors, and the sample met all related specifications.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that products meet all medtronic quality specifications.The most likely root cause could not be identified because no problem was detected with the device.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: 10038135
• Report Number: 1717344-2020-00494
• Device Sequence Number: 14199795
• Product Code: GEI
• UDI-Device Identifier: 10884524000084
• UDI-Public: 10884524000084
• 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): 06/25/2020

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 Expiration Date: 07/25/2023
• Device Model Number: FT3000
• Device Catalogue Number: FT3000
• Device Lot Number: 82050141X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1