MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGAPOWER 1000 A GENERATOR; MEGA POWER 1000 A, GENERATOR

Model Number 1000

Device Problems Arcing of Electrodes (2289); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Scar Tissue (2060); Full thickness (Third Degree) Burn (2696)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2022.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.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: what is the severity of the burn? (please see degrees of burns below and choose one) o 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 o second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful o 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 surgeon experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? 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 reported that during an unknown procedure the surgeon was burned with arcing from the cautery device.Surgeon is ok and it is unknown which device or rf pad was used.

Manufacturer Narrative

(b)(4).Date sent: 9/19/2022 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) o 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 o second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful o third degree burn the burn site looks deep, whitening or blackened and charred -the burn was a focal 3rd degree burn.It was immediately charred.The char eventually sloughed and it healed leaving a small scar.What medical intervention was used to treat the burn? (such as salve or stitches) just bacitracin to the area besides the burn, did the surgeon experience any adverse consequence due to the issue? no are there any anticipated long-term effects from the burn or injury? no additional information received: the rep was not in the room when the event took place.They set aside the generator and the biomed checked it out and it checked out fine.They use both megadyne sticky pad and megasoft.Do not know the endofactor that was used, it was not megadyne.No generator alert screens, or errors were given.Not sure if cut or coag was used during the incident.Too minimal to take a photo of both and soap and water was used to treat burn.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? was there any injury to the patient due to the incident? how was the device was being used at the time of the arcing? what pencil was being used? what other metal instruments were in the surgical field? any photos of the burn that you can share? any photos of the electrode that was used? what electrode was being used? was there any insulation damage on the electrode? was the surgeon holding any metal devices? if not, how close was the surgeon to the activation of the device? what step of the procedure was being done while the arching took place? was the surgeon touching target tissue when they were activating during the arching? did the surgeon activate on or in close proximity to the tissue? was the arching from the tip of the electrode? did the arching come from the insulation area? what was the procedure? what was the power settings on the generator? is the device being returned? were there any defects identified in the surgeon¿s gloves? what returned electrode was being used (sticky pad or megasoft) was being used for the procedure? what was the room set up? what was being used during the issue, cut or coag? what is the serial number of the generator?.

• Brand Name: MEGAPOWER 1000 A GENERATOR
• Type of Device: MEGA POWER 1000 A, GENERATOR
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15216314
• MDR Text Key: 302577540
• Report Number: 1721194-2022-00070
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103715
• UDI-Public: 10614559103715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050579
• 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: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000
• Device Catalogue Number: 1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1