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); Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that the assisting surgeon was burned by the arcing of the cautery device.The patient was an injured.Unknown brand of cautery and rf pad.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2022.An analysis of the product could not be performed since a physical sample was not received for 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.No serial number was provided therefore a device history could not be done.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) 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 surgeon experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? the event description states ¿the patient was an injured¿.Did the patient suffer any consequences? if yes, what were the consequences? 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.

Manufacturer Narrative

(b)(4).Date sent: 9/12/2022.Additional information was requested, and the following was obtained: what returned electrode was being used (sticky pad or megasoft) was being used for the procedure? sticky pad.What was the room set up? not sure, was not in the room.What was being used during the issue, cut or coag? not sure, was not in the room.What is the serial number of the generator? not sure.Additional information received: the rep was not in the room when the event took place.Low sense of urgency.They set aside the generator and the biomed checked it out and it checked out fine.The account had a mandatory meeting on the use of the generator.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.

Manufacturer Narrative

(b)(4) date sent: 9/6/2022 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) - answer: 2mm 2nd degree burn with 6 mm total burn area of 1st degree burn * what medical intervention was used to treat the burn? (such as salve or stitches) - answer: burn area was scrubbed with soap and water.Bacitracin applied day of burn.No further treatment subsequently.* besides the burn, did the surgeon experience any adverse consequence due to the issue - answer: burn completely healed with minimal scar * are there any anticipated long-term effects from the burn or injury? - answer: no is the megadyne generator currently being used in the facility.Yes if no, why not? was there any injury to the patient due to the incident? no how the device was being used at the time of the arcing? touching debakey forceps that was holding tissue what pencil was being used? what other metal instruments were in the surgical field? debakey forceps any photos of the burn that you can share? too poor quality any photos of the electrode that was used? no what electrode was being used? was there any insulation damage on the electrode? no was the assisting surgeon holding any metal devices? yes, forceps if not, how close was the assistant surgeon to the activation of the device? see below what step of the procedure was being done while the arching took place? cauterizing blood vessel was the surgeon touching target tissue when they were activating during the arching? only with debakey did the surgeon activate on or in close proximity to the tissue? no was the arching from the tip of the electrode? no did the arching come from the insulation area? no, the arching came from the debakey being held by assistant.What was the procedure? excisional biopsy mass.What was the power settings on the generator? 30/30 is the device being return? no can you please confirm the expiration date of the pad? 2023 to clarify, the resident was the surgeon holding the bovie to the forceps being held by the assistant who is the one burned.The electricity arched from the debakey through the surgeons glove to his index finger.B1, b2, h1.File was a malfunction file, but after additional information, the file is now a serious injury file.

• 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: 15197992
• MDR Text Key: 302176461
• Report Number: 1721194-2022-00069
• 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,Followup
• Report Date: 09/12/2022

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
• 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
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 09/12/2022
• Supplement Dates FDA Received: 09/06/2022; 09/12/2022
• 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
• Patient Outcome(s): Required Intervention