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

Model Number 0845

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 10/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the 0845 pad was returned with discoloration on the top surface and small tears were noted.The pad was tested with a generator and it worked as expected.No evidence was found that could contribute to the reported event.The most likely cause of this damage is related to the cleaning process.Please be aware that most cleaning agents leave residual active ingredient chemicals on the surface of the devices that are cleaned.For this reason megadyne recommends rinsing the cleaner/disinfectant off of the surface of the pad.It is possible that the tears noted on the returned sample could be possibly caused by exposing the pad to other equipment or may be a result of improper handling.Megadyne recommends reviewing proper use and handling techniques, as described in the instructions for use provided with the pad, with the appropriate personnel to prevent or minimize the possibility of this type of damage.This review should emphasize careful rinsing and drying of the device.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.Lot: gs22018117.Exp.Date 2024-07.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) 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? current patient status? answers = severity of burn? grade 1.Unknown on adverse consequences? doesn¿t believe so.Long term effect? unknown.The megasoft pad is code 0845 and (b)(4).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 pad currently being used in the facility.If no, why not? what medical intervention was used to treat the burn? (such as salve or stitches) what is the current status of the patient? how was the patient positioned? how was the room set up to include patient set up and where was the pad in relation to the patient? was there anything between patient? was the pad rinsed and let dry before it on this surgical procedure? how was pad cleaned? does the surgeon believe there is there an alleged deficiency to the pad 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 generator was being used? what power levels was generator set to? what was the endofactor that was being used? was a warming device used and if so brand and location? do we have an estimate of activation time? were there liquids used in prep? was urine or other fluids detected in the field after surgery? 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 craniotomy procedure, the patient had a burn reaction.The patient was undergoing neuro monitoring with probes that were set at the left wrist and both ankles.After the procedure was completed, they noticed the burns after they were removing the probes.The neuro monitoring rep stated in the case that she heard of these instances occurring with these megasoft pads.They are monitoring the patient.

Manufacturer Narrative

(b)(4).Date sent: 1/10/2023.Photo analysis: this is an analysis of a set of images / an image submitted to for evaluation.On the photos, there are two burn spots: the large one is oval shape with a dark central area surrounded by redness; the small burn spot shows blacken center with irregular skewed redness surrounding.Both burn injury appears to be deep second or third-degree burn.Based on the event description that ¿neuro monitoring with probes that were set at the left wrist and both ankles¿ during the surgical procedure, the burn spots correspond well with the location of the neuro monitor probes at the ankle area, likely to be caused by altered current flow.No conclusion could be reached as to how this issue occurred through photo analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.H10 manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 6/7/2023.Additional information received: the megasoft pad was used during a craniotomy while also using a needle electrode monitoring system.The rep indicated that the account switched to the megasoft pad during the sticky pad shortage.The neuro group was trained with it at that time.After the patient sustained the small, very oval-like, burns, the neuro group decided to stop using the megasoft pads until the reps had done their thorough investigation.Our reps tried to push the needle probe company to investigate their device as well, but they essentially indicated that the pad was the cause of the burns since it was the new product in the procedure.In the analysis received by the reps, it indicated that our ifu recommends not using the pads with the needle monitoring system.The ifu statement about not using electro surgery with needle monitoring electrodes is required by an international safety standard.This type of warning is in all electro-surgical (monopolar) equipment ifus, not just megasoft.Using electro surgical equipment with the needle monitory system has an inherent risk and that there are known hazards.We cannot as a company promote the usage of the 2 together since there is an inherent risk and we¿d be going against our ifu.It was also discussed why tattoos, piercings, and implants are okay, but needle electrodes are not.It has to do with them being isolated where the needle electrodes are connected to something else.

• Brand Name: MEGASOFT UNIVERSAL
• Type of Device: 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 ; 3035526892
• MDR Report Key: 16067407
• MDR Text Key: 306326048
• Report Number: 1721194-2022-00121
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133726
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0845
• Device Catalogue Number: 0845
• Device Lot Number: GS22018117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention