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	Seroma (2069)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Title: comparison of energy-based tissue dissection techniques in abdominoplasty: a randomized, open-label study including economic aspects source: aesthetic surgery journal 2019, vol 39(5) 536¿543 date of online publication: july 17, 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed between april 2014 and june 2016 post-operative complications of wound healing disorders occurred in a total of 19 patients (33%), including fat necrosis and infections; however these rates were comparable between groups: 7 ep, 4 peak, 3 hs and 5 apc, p=0.496.Seroma occurred in 7 patients, with comparable numbers between groups (p-value not provided); the highest number of seromas occurred with the use of hs (3), followed by 2 ep, and in 1 peak and 1 apc patient.Hematomas occurred in 4 total patients: 3 ep and 1 hs.

• 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: 9819579
• Report Number: 1717344-2020-00280
• Device Sequence Number: 14224597
• Product Code: GEI
• UDI-Device Identifier: 10884524000084
• UDI-Public: 10884524000084
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K051627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

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 Number: FT3000
• Device Catalogue Number: FT3000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R201911-09
• Patient Sequence Number: 1
• Patient Age: 38 YR