MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ELECTROSURGICAL GENERATOR; INSTRUMENT, ULTRASONIC SURGIICAL

Model Number MEGEN1

Device Problems Arcing of Electrodes (2289); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Serial number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was obtained: what is the severity of the burn? (please see degrees of burns below and choose one): the degree of the burns suffered by patient are unknown.The patient was moved to the burns or upon completion of procedure.What is the current status of the patient?: unknown are there any anticipated long-term effects from the burn or injury?: unknown.Additional information provided: the degree of the burn is unknown.The generators and pads were installed 2021.There was sometimes when the generator would not give energy at all and some would give too much.There are still arching and the sparking with the generator they have been fires.Stryker smoke pencil and 3m sticky pad used.They are not sure of the surgical procedure.3m sticky pad was used.The issues with stryker has been reported to stryker but all of the pencils were discarded so no analysis were completed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: is the megadyne generator currently being used in the facility.If no, why not? are there any photos of the burn that you could share with us in regards to the burn? if yes, please send to (b)(4).When were the burns first noticed? what is the severity of the burn? (please see degrees of burns below and choose one): first degree burns are minor burns on the first layer of skin.The skin looks dry, redness, and may be swelling; no penetration or blisters.Second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful.Third degree burn the burn site looks deep, whitening or blackened and charred what medical intervention was used to treat the burn? (such as salve or stitches) besides the burn, did the patient experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? what is the current status of the patient? what was the surgical procedure? how long did the surgical procedure last? how was the patient positioned? how was the room set up to include patient set up and where was the generator in relation to the patient? does the surgeon believe there is there an alleged deficiency to the generator that led to patient burn and if so why? was there any patient warming blankets used? if yes what warming blankets were used? what brand of warming blanket was used? is it possible the patient was in contact with a metal portion of the or table? what power levels was generator set to? was a warming device used and if so brand and location? were there liquids used in prep? was urine or other fluids detected in the field after surgery? were any foot pedals being used? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during the unknown procedure there was a fire incident involving the stryker smoke evacuation pencil.The megen1 was in use during this case.Traditional sticky pads were used.There was an open oxygen source.The patient suffered severe burns from the fire and was transferred to the burns center post op.The surgery was completed.

Manufacturer Narrative

(b)(4).Date sent: 4/11/2023.Additional information was requested, and the following was obtained: is the megadyne generator currently being used in the facility.If no, why not? -no.They pulled the generator from this case out of service until further info was gathered.They have since asked to put generator back into service.Are there any photos of the burn that you could share with us in regards to the burn? if yes, please send to productcomplaint1@its.Jnj.Com -no.When were the burns first noticed? immediately.What is the severity of the burn? (please see degrees of burns below and choose one) -2nd degree on face and 3rd degree small area on back.What medical intervention was used to treat the burn? (such as salve or stitches) -patient was transferred to doctors hospital burns or and pro actively intubated during case.Besides the burn, did the patient experience any adverse consequence due to the issue? -they were not able to finish surgery¿ patient came back once healed and surgery was completed to remove the additional melanoma tumor off face.Procedure went well.Are there any anticipated long-term effects from the burn or injury? ¿ no; patient is in beginning stages of dementia and had anxiety after procedure but has since done well.What is the current status of the patient? -patient has healed and has had the procedure completed.What was the surgical procedure? ¿ removal of melanoma on back and face¿were able to complete removal of melanoma on back but not face.How long did the surgical procedure last? ¿ 4 hours and 33 minutes.How was the patient positioned? ¿ supine.How was the room set up to include patient set up and where was the generator in relation to the patient? -unknown.Does the surgeon believe there is there an alleged deficiency to the generator that led to patient burn and if so why? -no.Was there any patient warming blankets used? -no.If yes what warming blankets were used? what brand of warming blanket was used? is it possible the patient was in contact with a metal portion of the or table? -patient was on a bean bag and megasoft pad.What power levels was generator set to? -unknown.Was a warming device used and if so brand and location? -no.Were there liquids used in prep? -yes; chloraprep was used.Patient had a very large goatee was urine or other fluids detected in the field after surgery? -no.Were any foot pedals being used? -unknown.

• Brand Name: ELECTROSURGICAL GENERATOR
• Type of Device: INSTRUMENT, ULTRASONIC SURGIICAL
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16609008
• MDR Text Key: 311958249
• Report Number: 1721194-2023-00054
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559105597
• UDI-Public: 10614559105597
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEGEN1
• Device Catalogue Number: MEGEN1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention