MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. 15FT SMOKE PENCIL UCONN; RETURN ELECTRODE CABLE, DUAL PLATE

Model Number	251015J
Medical Device Problem Codes	Flaked (1246); Difficult or Delayed Activation (2577); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unknown procedure the bovi arced, caught the drape on fire, and the patient suffered a severe burn.No other information is available.
Additional Manufacturer Narrative
(b)(4).Date of event: unknown, assumed 1st day of month that event took place.Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.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: 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? does the surgeon believe there is there an alleged deficiency to the device that led to patient burn and if so why? how long was the bovie¿s activation time?.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/17/2021.Additional information was requested, and the following was obtained: are there any photos of the burn that you could share with us in regards to the burn?- no photos are available.When were the burns first noticed? immediately.What is the severity of the burn? surgeon described the burn as a "sun burn".What medical intervention was used to treat the burn? unknown.Besides the burn, did the patient experience any adverse consequence due to the issue? none reported.Are there any anticipated long-term effects from the burn or injury? none reported.What is the current status of the patient? unknown - patient has not returned for follow up visit.What was the surgical procedure? facial cyst removal.Does the surgeon believe there is there an alleged deficiency to the device that led to patient burn and if so why? surgeon stated he is unsure if the device/bovie used was an ethicon device/bovie and if it was an ethicon device/bovie he does not believe our device was at fault.How long was the bovie¿s activation time? unknown what was the target tissue when the arching occurred? facial.What was the generator settings? unknown were you in contact with the tissue when activating? unknown.What type of pad was being used? unknown.Are there any pictures of the device that can be sent? none.Was the device cleaned correctly? unknown.Was there any damaged noticed on the endofactor? none reported.What was the location of the burn? face.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: 15FT SMOKE PENCIL UCONN
• Common Device Name: RETURN ELECTRODE CABLE, DUAL PLATE
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kara ditty-bovard ; 11506 south state street; draper, UT 84020 ; 6107428552
• MDR Report Key: 12770991
• Report Number: 1721194-2021-00081
• Device Sequence Number: 4217561
• Product Code: GEI
• UDI-Device Identifier: 10614559105580
• UDI-Public: 10614559105580
• Combination Product (Y/N): N
• PMA/510(K) Number: K982130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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
• Operator of Device: Health Professional
• Device Model Number: 251015J
• Device Catalogue Number: 251015J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown