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

Model Number FORCEFX-CS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Shock (2072); Anxiety (2328); Discomfort (2330); Deformity/ Disfigurement (2360); Depression (2361); Full thickness (Third Degree) Burn (2696)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during breast augmentation, the doctor smelled burning.Upon investigation, the doctor discovered that there was a third degree burn located on the patients leg where the patient return electrode was located.The burn was approximately 9cm in length.The doctor repaired the burn right away after it was discovered on the patient's leg.

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 breast augmentation, the doctor smelled burning.Upon investigation, the doctor discovered that there was a third degree burn located on the patients leg where the non-medtronic patient return electrode was located.The burn was approximately 9cm in length.The doctor repaired the burn right away after it was discovered on the patients leg.The energy from the generator continued to delivered even though it was visible from the pre (patient return electrode) that heat had built up on one side of the return electrode.The contact quality monitoring system should had activated to disable the energy once the resistance differential was too high and there was no error code or alarm that sounded at the time of the incident.The surgeon had another device with electrosurgery on board.No further information available.

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

The patients attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a bilateral breast augmentation.It was reported that during surgery, the doctor smelled burning.Upon investigation, the doctor discovered that there was a third degree burn located on the patients leg where the non-medtronic patient return electrode was located.The burn was approximately 9cm in length.The doctor repaired the burn right away after it was discovered on the patients leg.The energy from the generator continued to delivered even though it was visible from the pre (patient return electrode) that heat had built up on one side of the return electrode.The contact quality monitoring system should have activated to disable the energy once the resistance differential was too high and there was no error code or alarm that sounded at the time of the incident.The surgeon had another device with electrosurgery on board to finish the procedure.It was reported that due to the surgery, the patient experienced scarring, pa in, discomfort, disfigurement, shock, anxiety, emotional trauma, depression, suffering and loss of enjoyment of life.Post-operative patient treatment included medical treatment, hyperbaric oxygen therapy and medication.No further information available.

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

The patients attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a bilateral breast augmentation.It was reported that during surgery, the doctor smelled burning.Upon investigation, the doctor discovered that there was a third degree burn located on the patients leg where the non-medtronic patient return electrode was located.The burn was approximately 9cm in length.The doctor repaired the burn right away after it was discovered on the patients leg.The energy from the generator continued to delivered even though it was visible from the pre (patient return electrode) that heat had built up on one side of the return electrode.The contact quality monitoring system should had activated to disable the energy once the resistance differential was too high and there was no error code or alarm that sounded at the time of the incident.The surgeon had another device with electrosurgery on board to finish the procedure.It was reported that due to the surgery, the patient experienced scarring, pain, discomfort, disfigurement, shock, anxiety, emotional trauma, depression, suffering and loss of enjoyment of life.Post-operative patient treatment included medical treatment and medication.

• Brand Name: FORCE FX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10434067
• MDR Text Key: 203798223
• Report Number: 3006451981-2020-00125
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524002620
• UDI-Public: 10884524002620
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEFX-CS
• Device Catalogue Number: FORCEFX-CS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 09/28/2020; 02/17/2022; 03/04/2022
• Supplement Dates FDA Received: 10/19/2020; 02/18/2022; 03/24/2022
• Date Device Manufactured: 01/13/2011
• 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 Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 46 KG