MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT UNIVERSAL; MEGA SOFT UNIVERSAL

Catalog Number	0845
Medical Device Problem Codes	Human-Device Interface Problem (2949); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a c-section the surgeon had the cautery in her left hand and was holding a snap in her right hand.The snap was attached to the patient and her right hand was resting/in contact with the abdomen, where the burn occurred.The surgeon pressed the cautery button to cauterize and felt a burning sensation in her right hand.The surgeon up with a red mark on her right hand.We¿ve removed the megadyne pad from the or for now until we sort out the issue.We¿ve been using the pads several times each day since they¿ve arrived and this is the first incident we¿ve had.There was no large pooling of fluid or anything abnormal about this case or set up.
Additional Manufacturer Narrative
(b)(4) date sent: 1/31/2024 investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned samples revealed that the 0845 pad and pigtail cable was returned with no apparent damage.The pad and cable were connected to the generator and no anomalies were noted.The returned pad did not contain any evidence related to the reported issue.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device sn (b)(6), and no non-conformances were identified.Additional information received: surgeon experience with the device? ¿ 6 months ¿ 2 years is the megadyne pad currently being used in the facility.¿ if no, why not? no, they have pulled the pads due to the incident.Is there any damage(s) noted on the pad? no how long has the account been using mega soft? approximately 2 years does the surgeon believe there is an alleged deficiency to the pad that led to burn and if so why? they are unsure of what happened.I personally think this may be a classic alternate site burn situation due to the metal clamp that was touching the patient and being held by the surgeon.When were the burns first noticed? a few minutes in, surgeon noticed a tingling on their hand which was touching the metal clamp.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)? unknown was the reported issue at the pad site or alternate site? alternate site (by metal clap) are there any anticipated long-term effects from the burn or injury? unknown what was the surgical procedure? c-section how long did the surgical procedure last? unknown what cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? an approved cleaner, cavi wipes.Was the pad rinsed with water and let dry before this surgical procedure? yes how was the patient positioned? supine is it possible the patient was in contact with a metal portion of the or table? doubtful but patient had metal clamp on them which was touching the surgeons hand, electricity takes the path of least resistance, which makes me think this could be an alternate site burn how was the room set up to include patient set up and where was the pad in relation to the patient? underneath patient with sheet, and thin soaker pad covering bottom 25% of pad.Was there anything between patient and the pad (ex.Sheet, drape, etc.)? see above were there liquids used in prep? unknown what skin preparation regiment was utilized for the procedure? unknown was urine or other fluids detected in the field after surgery? unknown was there any patient warming blankets used? unknown ¿ if yes, what warming device and/or blankets were used and what is the location in relation to the patient? what temperature setting was used on the warming device(s)? what generator was being used? force fx generator what power levels was generator set to? unknown was there any diminished effect of the generator noted during the surgery?no what monopolar disposables were used during the procedure? unknown the incident scared/worried the physician a little bit.The rep indicated that 2 pads were pulled from use.Pads have been in use for about 4 months.The rep indicated that 1 bedsheet was used along with a green soaker sheet on the patient.There is an additional 3rd blue sheet that the rep will follow up with the customer to determine what it is.The rep indicated that the placement of cables would not have been an issue in this incident based off the rep¿s knowledge of the procedure set-up.What¿s the blue sheet in the photograph? ¿be-light¿ drape that is nylon material in the middle and cotton material on the sides.It is a light weight material that makes transferring patients easier.Was the snap being held in her hand or was it clipped to her scrubs? surgeon was using snap as a bipolar forcep touching the bovie pen to it, as she usually does.Surgeon said there was redness on the side of her hand which was touching the patient where the patients skin blistered.This same hand was holding the metal snap.What are the details of the incident?: cautery current arced during surgery and burnt doctor performing the surgery.Cautery ground was switched from cautery pad underneath the patient on the bed to a sticker attached to patient's leg.Impact of incident: burn to the surgeon's finger (1st degree, no dressing required, some redness noted) 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/20/2024.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: MEGASOFT UNIVERSAL
• Common Device Name: MEGA SOFT UNIVERSAL
• 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 ; PR ; 3035526892
• MDR Report Key: 18619216
• Report Number: 1721194-2024-00010
• Device Sequence Number: 16745663
• Product Code: GEI
• UDI-Device Identifier: 10614559103906
• UDI-Public: 10614559103906
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 0845
• Device Lot Number: GS23033709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1998-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown