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 Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Date 11/01/2022

Event Type  Injury  

Event Description

It was reported that two days post op to a kidney procurement it was discovered the patient received a burn of unknown severity.During the procedure they used a metal clamp to secure the foley to a blanket which they were having an unknown issue with.No burn was noticed at the conclusion of the case.No further information is available at this time.

Manufacturer Narrative

(b)(4).Date of event: unknown, assumed 1st day of month that the event took place.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.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 serial number was provided therefore a device history could not be done.Additional information received: what is the location of the burn? left flank.Is a photo of the burn available? yes.What is the severity of the burn? 2nd degree / superficial partial thickness 15cmx12cm.What medical intervention was used to treat the burn? (such as salve or stitches) silvadene.Are there any anticipated long-term effects from the burn or injury? no long term effects outside the skin area.What is the current condition of the patient? doing well after transplant.What was the pad and patient position? on the bed pad, sheet placed over top supine, pad under body.Please describe the total room set up? standard kidney transplant with bovie, suction at foot of bed.Equipment at foot of bed.What was the total thickness between the skin and return electrode megasoft pad, to include any cover sheet? a sheet was placed.How was cable of the megasoft pad positioned? cable draped from foot to right shoulder.What is the age and weight of patient? 44years old, 210lb middle age hispanic male, normal weight, non-obese.What is the surgeons experience with using the pad? use only when the staff selects it.No formal training.What is the or staff¿s experience with using the pad? yes.How much of the body was touching the pad? none, there was a sheet, his shoulders, back, buttocks and legs were on the sheet.Sheet placed on bed over the pad.What was the power setting used on the generator? 40/40 ( according to chart) cut/coag 30-45.How are the pads cleaned in between use? wiped with purple top cleaner, air dry what cleaners are utilized? are the pads rinsed and let dry prior to use? no rising done in or, cleaning is done with purple top wipes ( sani cloth).We were made aware on (b)(6) 2022 that a patient presented with a burn two days post op.Surgeons experience is about 5 years.Unsure of where the burn came from.The surgeon is a transplant surgeon.Kidney procedure.The pad is on the bed, drawsheet over bed, not a lot of layers.Patient presented with burn 2 days post op.Patient is home now and doing fine.The entire system in 30 ors use megasoft and there has not been any issues and no burns.Rep was not in the room.There was an issue with the foley, and they used a scissor clamp about 4 inches long and they clamped the foley to the blue drape.The clamp was laying in the area where the burn happened.No report of burn, no report of patient saying there was ¿pain¿ in the recovery room or later.No sticky pad used.Patient in supine position.No generator alert screens that they know of.The megasoft pad is still in use.The sheet was not burned, the pad did not have any burns on it.Additional information was requested, and the following was obtained: does the surgeon believe there is there an alleged deficiency to the pad that led to patient burn and if so why? we have had no issues with the pad, and it has been used since.The esu machine was check by biomed, and confirmed in good working order.It is also being used.Was there any damage to the pad? a picture of the pad would be great if possible.No damage to pad, sheets or bed.What is the serial number of the pad? unknown.What kidney (left or right) was being removed? can you please describe more of the patient positioning just beyond ¿supine¿? supine, legs straight, blanket roll placed between legs.Arms extended, arm board, foam cradles, head aligned on foam donut.Brand name of ¿purple cleaner¿ solution? sani cloth.Please confirm if linen covered sheet or was folded linen draw sheet.In other words, was patient skin directly touching mega soft for what there a layer underneath? no, the sheet was over the pad.No direct contact.Was the injured area on the pad? we know there was a sheet between patient and the pad but was pad under the injured area? yes the injured area was under the pad.Were there any electrosurgical cables near the clamp that was mentioned? was there any patient warming blankets used? upper body, and lower body used, if yes, what warming blankets were used? bairhugger.Where was the location of the warming blankets? what brand of warming blanket was used? what was the endofactor that was being used? were there liquids used in prep? patient was prepped with alcohol 70%, painted with chlorhexidine.Was urine or other fluids detected in the field after surgery? how long was the activation time of the cautery? will the device be returning for analysis? 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: 1/17/2023.Additional information received: no liquid was in or around the area of the burn.There was a hemostat on the drape that they did not know if it could have caused the issue.The hemostat was between sheet and patient.The sheet or drape was not damaged or burn.The patient was not on the hemostat at all.The burn looked like a sunburn and then blistered the next day.The patient woke up in recovery and had extreme pain and redness and it got worse.Sani wipes are being used to clean the pad.There is no rinsing of the pad.Patient positioning was adjusted during the procedure.The pad is still being used in the procedure with no further issues.Photo analysis: this is an analysis of an image submitted for evaluation.A photo of left flank area taken after surgery shows an area of thermal burn injury.Half of the area skin was peeled off but the remain surface is red and dry.In other portion of burn area, there are a few blisters visible with skin being in dark brown color.No apparent swelling is observed.The skin burn presentation is consistent with the second degree burn appearance.No conclusion could be reached as to how this issue occurred through photo analysis.Because the instrument was not returned our evaluation is limited.

• 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: 16059811
• MDR Text Key: 306247086
• Report Number: 1721194-2022-00120
• 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
• Report Date: 01/17/2023

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: 0845
• Device Catalogue Number: 0845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/17/2023
• 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
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Hispanic