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

Model Number	FT3000
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/05/2018
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, prior to a laparoscopic partial nephrectomy, the device was activating although the activation button was not being pressed at that time.A new ft3000 was opened and it worked fine.Foot switch was not being stepped on at that time of issue.No patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one device sample was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product met specification as received.Visual inspection found no defects.The investigation found the device to function normally and within specifications.The device was recognized when plugged into a generator.The device was not self activating when plugged into the generator.The device was activated five times in all three modes and all five slider positions with no anomalies noted.The investigation found the device to function normally and within specifications.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: 7447320
• Report Number: 1717344-2018-00528
• Device Sequence Number: 11276121
• Product Code: GEI
• UDI-Device Identifier: 20884524000081
• UDI-Public: 20884524000081
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150735
• 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): 08/27/2018

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: 07/25/2022
• Device Model Number: FT3000
• Device Catalogue Number: FT3000
• Device Lot Number: 72050165X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1