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

Model Number FORCEFX-8C

Device Problems Failure to Deliver Energy (1211); Image Display Error/Artifact (1304); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/24/2021

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 radical thyroidectomy under general anesthesia of tracheal intubation, during the preoperative instrument detection, it worked normally and found no abnormality.At the beginning of the operation, the unit operated normally, and the operation lasted for about one hour.When the surgeon used the generator to stop bleeding, they found that the unit's screen suddenly flashed and could not stop bleeding normally.Immediately they replaced with another dissector to continue the operation.The occurrence of the event increased the risk of bleeding and prolonged the operation time.

Event Description

According to the reporter, during radical thyroidectomy under general anesthesia of tracheal intubation, during the preoperative instrument detection, it worked normally and found no abnormality.At the beginning of the operation, the unit operated normally, and the operation lasted for about one hour.When the surgeon used the generator to stop bleeding, they found that the unit's screen suddenly flickered, the dissector could not output so the bleeding could not be stopped.The bleeding was less that 250cc and the procedure was extended for about 10minutes.Immediately they replaced with another dissector to continue the operation.

Manufacturer Narrative

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 & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13010284
• MDR Text Key: 282278324
• Report Number: 1717344-2021-01648
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524001562
• UDI-Public: 10884524001562
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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
• Device Lot Number: 150971229-G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 96 KG