MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS FORCE FX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number FORCEFX-8CAS

Device Problems Device Alarm System (1012); Image Display Error/Artifact (1304); Self-Activation or Keying (1557); Device Displays Incorrect Message (2591); Connection Problem (2900); Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2021

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 use, the unit was not working, flashed lights, had an alarm and had an error log 17, 166 and 164.The autobipolar activated when shorted and the cut display was rupture.There was no patient injury.

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.

Event Description

According to the reporter, during use, the unit was not working, flashed lights, had an alarm and had an error log 17, 166 and 164.The autobipolar activated when shorted and the cut display was rupture.Replaced with another similar device and it worked fine.There was no patient injury.

Manufacturer Narrative

Additional information: g3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the keyboard is damaged and the k2 relay is worn.It was reported that the device self activated by itself without user input, the device had a functional issue with the bipolar port, the device displayed error code 164, the device displayed error code 166, the device displayed error code 17, the device had a screen issue, the device activated an alarm and the device had an electrical short.The reported issues were confirmed.The most likely cause could not be established from the information available.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.

Manufacturer Narrative

Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit had a circuit board failure and had an ic (integrated circuit) failure.The unit had also a relay failure.It was reported that the device self-activated by itself without user input and had a functional issue with the bipolar port.The device displayed error code 164, 166, 17 and had a screen issue.The device also activated an alarm and had an electrical short.The reported issues were confirmed.The most likely root 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.

Event Description

According to the reporter, prior to use, the unit was not working, flashed lights, had an alarm and had an error log 17, 166 and 164.The autobipolar activated when shorted and the cut display was rupture.Replaced with another similar device and it worked fine.There was no patient involvement.

• Brand Name: FORCE FX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12634866
• MDR Text Key: 276468352
• Report Number: 3006451981-2021-00134
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524002637
• UDI-Public: 10884524002637
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEFX-8CAS
• Device Catalogue Number: FORCEFX-8CAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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