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

Model Number FORCEFX-8C

Device Problems Inaccurate Delivery (2339); Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during set-up, the unit had a rem abnormality warning and the signal remained green when it should not.Another generator was used and it worked fine.There was no patient involvement.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the unit had a failure due to calibration.This issue was resolved by calibration of the device.It was reported that the device had an unknown return electrode monitoring (rem) issue.The reported issue was confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORCE FX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 10241119
• MDR Text Key: 197843678
• Report Number: 1717344-2020-00701
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524001562
• UDI-Public: 10884524001562
• Combination Product (y/n): N
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

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
• Device Operator: Health Professional
• Device Model Number: FORCEFX-8C
• Device Catalogue Number: FORCEFX-8C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1