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

Model Number 0830

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

Patient Problems Discomfort (2330); Partial thickness (Second Degree) Burn (2694)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 5/24/2023.A manufacturing record evaluation was performed for the finished device sn: (b)(6) and no non-conformances were identified.Additional information was requested, and the following was obtained: could you please confirm 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 ¿ confirmed 2nd degree.Area of injury blistered and was 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) iodine and dry dressing.Besides the burn, did the patient experience any adverse consequence due to the issue? discomfort at the site of injury.Are there any anticipated long-term effects from the burn or injury? no.What is the current status of the affected (patient or user)?healing stage.Continues follow up with physician care provider.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? are there any photos of the burn (s) that you could share with us in regards to the burn? if yes, please send to (b)(4).How long has the account been using mega soft? does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? when were the burns first noticed? where is the burn located on the patient? was the reported issue at the pad site or alternate site? what was the surgical procedure? how long did the surgical procedure last? what cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? was the pad rinsed with water and let dry before this surgical procedure? how was the patient positioned? is it possible the patient was in contact with a metal portion of the or table? 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 and the pad (ex.Sheet, drape, etc.)? were there liquids used in prep? what skin preparation regiment was utilized for the procedure? was urine or other fluids detected in the field after surgery? was there any patient warming blankets used? 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? what power levels was generator set to? was there any diminished effect of the generator noted during the surgery? what monopolar disposables were used during the procedure? what is the age of the patient? 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 an unknown procedure that while on a megasoft patient return electrode pad, the patient had a small burn in a area where it was identified that the patient was touching the metal positioning bar.It was also reported that on visual inspection, the pad did not have any areas on it that might be compromised.

Manufacturer Narrative

(b)(4).Date sent: 6/7/2023.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 0830 pad and cable were returned with no apparent damage.The pad and cable were connected to the generator and no anomalies were noted.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.Additional information was requested, and the following was obtained: 1.Is the megadyne pad currently being used in the facility.If no, why not? yes 2.Are there any photos of the burn (s) that you could share with us in regards to the burn? if yes, please send to productcomplaint1@its.Jnj.Com no 3.How long has the account been using mega soft? 10+ years 4.Does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? unknown 5.When were the burns first noticed? intra-op 6.Where is the burn located on the patient? arm 7.Was the reported issue at the pad site or alternate site? alternate 8.What was the surgical procedure? unknown at this time 9.How long did the surgical procedure last? unknown at this time 10.What cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? 11.Was the pad rinsed with water and let dry before this surgical procedure? no 12.How was the patient positioned? 13.Is it possible the patient was in contact with a metal portion of the or table? surgical staff identified that the patient contacted a metal positioning bar attached to or table.14.How was the room set up to include patient set up and where was the pad in relation to the patient? 15.Was there anything between patient and the pad (ex.Sheet, drape, etc.)? 16.Were there liquids used in prep? 17.What skin preparation regiment was utilized for the procedure? 18.Was urine or other fluids detected in the field after surgery? 19.Was there any patient warming blankets used? if yes, what warming device and/or blankets were used and what is the location in relation to the patient? 20.What temperature setting was used on the warming device(s)? 21.What generator was being used? medtronic ft10 22.What power levels was generator set to? unknown 23.Was there any diminished effect of the generator noted during the surgery? unknown 24.What monopolar disposables were used during the procedure? unknown 25.What is the age of the patient? unknown.

• Brand Name: MEGASOFT
• Type of Device: MEGA SOFT
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16994934
• MDR Text Key: 315878792
• Report Number: 1721194-2023-00084
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559101797
• UDI-Public: 10614559101797
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0830
• Device Catalogue Number: 0830
• Device Lot Number: GS22034157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention