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

Catalog Number 0846

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

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/30/2023

Event Type  Injury  

Event Description

It was reported that during a cabg the patient suffered a burn while using megasoft patient return electrode.The procedure was successfully completed.

Manufacturer Narrative

(b)(4).Date sent: 8/14/2023 attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot or batch number was provided therefore a device history could not be done.Photo images photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.Additional information was requested, and the following was obtained: is the megadyne pad currently being used in the facility.Yes.Are there any photos of the burn (s) that you could share with us in regards to the burn? no.Are there photos that can be shared of the pad? no.How long has the account been using mega soft? 6 months.When were the burns first noticed? back.Where is the burn located on the patient? back.Was the reported issue at the pad site or alternate site? pad site.Besides the burn, did the patient experience any adverse consequence due to the issue?- no.Are there any anticipated long-term effects from the burn or injury? no.What was the surgical procedure? cabg.How long did the surgical procedure last? 4 hrs.What cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? saline water.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? no.How was the room set up to include patient set up and where was the pad in relation to the patient? below the patient's back.Was there anything between patient and the pad (ex.Sheet, drape, etc.)? 2 linen.Were there liquids used in prep? chlorhexidine.What skin preparation regiment was utilized for the procedure? chlorhexidine and sterilium.Was urine or other fluids detected in the field after surgery? no.Was there any patient warming blankets used? yes.If yes, what warming device and/or blankets were used and what is the location in relation to the patient? maquet hcu, below the megasoft.What temperature setting was used on the warming device(s)? 37 degrees.What generator was being used? covidien.Was there any diminished effect of the generator noted during the surgery? no.What monopolar disposables were used during the procedure? valley lab.Is there any damage(s) noted on the pad? no damage additional information received: the customer indicated that there was a sheet between the patient and the pad, the pad was cleaned with saline, and the burns were discovered immediately after the 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.

Manufacturer Narrative

(b)(6).Date sent: 8/23/2023 photo analysis: this is an analysis of an image submitted for evaluation.(b)(6)-case 1: a single photo of patient back was evaluated.According to reporting, the patient underwent cabg procedure on (b)(6)2023.A rod shaped burn is seen at the right scapula of upper back on the photo.The superficial skin of the burn is charred with areas of peeling off.No significant skin swelling or blisters are observed.Mild skin redness is also evident on the other side of the shoulder blade.The degree of skin burns was first to second degree.The cause of the burns could not be determined from the photos.No conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.

Manufacturer Narrative

(b)(4).Date sent; 3/14/2024.

• Brand Name: MEGASOFT UNIVERSAL DUAL
• Type of Device: MEGA SOFT UNIVERSAL DUAL
• 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: 17543365
• MDR Text Key: 321098725
• Report Number: 1721194-2023-00104
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559104248
• UDI-Public: 10614559104248
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K133726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2001-2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female