MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VLFT10GEN

Device Problems Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Scar Tissue (2060); Full thickness (Third Degree) Burn (2696); Unspecified Tissue Injury (4559)

Event Date 02/06/2024

Event Type  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 reporter, during procedure, the patient was operated with the insertion of breast implants on a cosmetic basis.The first part of the operation was done without any complications.Incisions were made under each breast where the prostheses were to be inserted and there were hole spaces (pockets) established over the muscle.During surgery, it was noted that the coagulation button did not work several times at the first press of the button.However, by repeated pressing the button, it seemed normal.It was communicated to the operating nurse, and it was ensured that the diathermy plate had good contact and there were no error messages from the diathermy device.When the pockets were completed and meticulous hemostasis (blood position with diathermy) had been performed, the pockets should be rinsed with sterile saline prior to loading the prostheses.While irrigating the pocket on the right side with salt water, the undersigned noticed excessive heat against the glove.Large flames and extremely rapid development of fire were now detected, where the sterile coverage attached around the surgical site caught fire.There was fire from the diathermy pencil or diathermy line one hour into the procedure.To extinguish the flames by the anesthesiologist, the disposable shirt she was wearing also caught fire.Fortunately, she got this off and threw it on the floor and then got the flames extinguished by stepping on it.The flames were put out as fast as possible, and help was called.The fire extinguisher was picked up immediately by staff at the clinic, but then the fire was already extinguished.The patient had sustained third degree burn on her right chest and right arm.Cooling with large fire compresses and cold sterile saline was immediately started.Refrigerated for at least 20 minutes.Removed loose skin and covered all burns with moist compresses.Disinfects the surgical field with chlorhexidine and sew skin incisions in three layers.Wounds are bandaged with moist compresses, dry compresses and circular dressings.The patient was awakened from general anesthesia and pain relieved with a combination of iv painkillers and tablet painkillers.Patient was conferred with the attending plastic surgeon at hospital who conferred with the arrangement of admission to another hospital.No further patient complication reported.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to reporter, during an insertion of breast implants on a cosmetic basis procedure, the first part of the operation was done without any complications.Incisions were made under each breast where the prostheses were to be inserted and there were hole spaces (pockets) established over the muscle.It was noted that the coagulation button did not work several times at the first press of the button.However, by repeated pressing the button, it seemed normal.It was communicated to the operating nurse, and it was ensured that the diathermy plate had good contact and there were no error messages from the diathermy device.When the pockets were completed and meticulous hemostasis (blood position with diathermy) had been performed, the pockets should be rinsed with sterile saline prior to loading the prostheses.While irrigating the pocket on the right side with salt water, the undersigned noticed excessive heat against the glove.The sterile drapes attached to the patients thorax had caught fire.Large flames and extremely rapid development of fire were now detected, where the sterile coverage attached around the surgical site caught fire.There was fire from the diathermy pencil or diathermy line one hour into the procedure.To extinguish the flames by the anesthesiologist, the disposable shirt she is wearing also caught fire.Fortunately, she gets this off and throws it on the floor and then gets the flames extinguished by stepping on it.The flames were put out as fast as possible, and help was called.The fire extinguisher was picked up immediately by staff at the clinic, but then the fire was already extinguished.Patient was under laryngeal mask airways (lma) anesthesia and chorohexidin was used in skin prep 45 minutes prior to the incident and was therefore completely dry at the time of the fire.The patient suffered extensive burn wounds to her right thorax and right upper extremity of second and third degree wounds of approx 5% tbsa which was skin grafted the following day.Cooling with large fire compresses and cold sterile saline was immediately started.Refrigerates for at least 20 minutes.Removes loose skin and covered all burns with moist compresses.Disinfects the surgical field with chlorhexidine and sew skin incisions in three layers.Wounds are bandaged with moist compresses, dry compresses and circular dressings.The patient was awakened from general anesthesia and pain relieved with a combination of iv painkillers and tablet painkillers.Patient was conferred with the attending plastic surgeon at hospital who conferred with the arrangement of admission to another hospital.No further patient complication reported.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the coagulation button did not work several times at the first press of the button.The sterile drapes attached to the patients thorax had caught fire.There was fire from the diathermy pencil or diathermy line one hour into the procedure.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VALLEYLAB FT10
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18813580
• MDR Text Key: 336731315
• Report Number: 1717344-2024-00583
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K151649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLFT10GEN
• Device Catalogue Number: VLFT10GEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2023
• 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): Required Intervention; Hospitalization; Other
• Patient Sex: Female