MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB FX8; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VLFX8GEN

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

Patient Problems Superficial (First Degree) Burn (2685); No Code Available (3191)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, intra-operatively, a spark from the electrosurgical pencil extended to surrounding or (operating room) field and plastic protections.After this incident health care professional removed all the plastic protections in flames from the patient to the ground, and remove immediately patient from the operating room.The patient had first degree burn and treated by moisturizing cream.They had to close the surgical wound in a different operating room after the incident.The procedure was aborted.The patient extended the hospitalization by 2-3 days.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted excess of ashes inside the device and wrong fuses were found in the device.The analysis/evaluation found that the device was in a very bad state due to the excess of ashes inside the device.The power supply was damaged, it is believed due to the amount of ashes accumulated on it.It is also believed that the device failed after the fire started, not the other way around.It was reported that there was an adverse event without an identified device or use problem.A potentially related device issue could not be confirmed.The most likely cause was not traced to the device.It was also reported that there was an operating room fire without injury.The reported issue could not be confirmed.The most likely cause was not traced to the device.The evaluation detected an unreported condition: the unit had a fuse failure and had a power supply failure.The product analysis noted evidence that the device was not used as intended.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.

Event Description

According to the reporter, intra-operatively, a spark from tip during coagulation of a non medtronic electrosurgical pencil extended to surrounding or(operating room) field and plastic protections.After this incident health care professional removed all the plastic protections in flames from the patient to the ground, and then extinguished by the fireman.Then, remove immediately patient from the operating room.The patient had 1st degree burn and treated by moisturizing cream.They had to close the surgical wound in a different operating room after the incident.The procedure was aborted.The patient extended the hospitalization by 2-3 days.The generator setting was cut: 35, blend.Coag: 35, fulgurate.

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: VALLEYLAB FX8
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 10599978
• MDR Text Key: 208960138
• Report Number: 1717344-2020-01124
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521707306
• UDI-Public: 10884521707306
• Combination Product (y/n): N
• PMA/PMN Number: K172757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLFX8GEN
• Device Catalogue Number: VLFX8GEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 79 YR