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

Model Number 0840

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

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694); Swelling/ Edema (4577)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Photo was provided for review by ethicon medical safety officer.Following are their observations: images 1: photo shows oblique view of almost entire back of the patient body.There is burn wound extend from upper to lower part of left back.The affected skin shows redness with generally only superficial skin layer involved but skin incrustation can be seen in the upper middle area.Image 2: in another photo of mainly left side of buttock, a large area of skin burn is observed with peel off of the superficial skin layer and various degree of redness can also be seen.The affected skin is likely representing a second degree of burn injury.According to surgeon¿s reporting, the patient was rolled from supine position to a left lateral position to allow for a spinal to be performed at the end of the procedure.During this time there was nothing noticed on the patients skin, no redness and no broken skin, the patients skin was in-tact.Then 24hrs later the patient complained an uncomfortable feeling in the back, a bubbly and sore feeling, on inspection the area was red with superficial swelling with some red spots initially.It was then also noted that there was a deeper broken area on the patients buttock.While the photos alone could not determine the potential cause of the burn injury, the description on burn occurrence/detection time makes it unlikely to be caused by megasoft burn injury, which should be noted immediately following the procedure.No conclusion could be reached as to the root cause of the reported issue.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.The batch history records were reviewed and certified by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.The certificate records are accessible through external manufacturing.Additional information received: the operation was a robotic low anterior resection using the de vinci robot.The patient was placed directly on the megasoft pad-they remove the blue draw sheet when positioning the patient in theatre.No alarms sounded from the erbe generator throughout the procedure.The patient was supine and in lithotomy position during surgery.The pad and cable have been isolated but the hospital cant release them at the moment , in accordance with their internal process.I have asked them to let me know as soon as they are available.The electro surgery generator was a erbe which is part of the da vinci robotic stack.Alcoholic chlorhexidine gluconate was the skin prep used 0.70ml/ml strength-in a prepared sponge applicator so there was only limited amount of the fluid and there was no obvious evidence that any pooling of fluid had occurred under the patient.Also, the patient was asleep at 1340 with the first port introduced at this time, the robot was docked at 1356 and diathermy was first used at 1402 which suggests that the skin prep had at least 20 minutes to dry.At the end of the procedure the patient was rolled from supine position to a left lateral position to allow for a spinal to be performed.During this time there was nothing noticed on the patients skin, no redness and no broken skin, the patients skin was in-tact.Then 24hrs later the patient complained that they felt an uncomfortable feeling in their back, a bubbly and sore feeling, on inspection the area was red with superficial swelling with some red spots initially.It was then also noted that there was a deeper broken area on the patients buttock.The patient was also checked by the tissue viability nurse.Photos were taken and sent to the (b)(6) hospital (b)(6), a specialized burns center and they suggested that this was a burn.The area was treated with a localized cream.This patient remains an in patient but i was told is recovering well.They have removed all their megasoft pads from use at this time.Was the product being used in a clinical trial? no.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? no.Event outcome/how was it managed? post op electrosurgery burn.Was there any consequence to the patient due to the event? electrosurgery burn on back of patient.Was the surgery prolonged due to the event? if yes, confirm how many minutes delay no, discovered after op.Has the reporter facility indicated there may be legal action? no.The patient was placed directly on the pad.They have always done this with all procedures.Supine position.There was no fluid under the patient.20 min from skin prep to time the diathermy was used.No red or skin breakage after surgery.24 hours later the patient felt pain and soreness.They observed and this when they saw the burns on patient.Treated with cream and was in-patient stay due to burn.Used clinell wipes to clean the pad even before they switched megasoft pad.They have been using the pads since 2019.Not sure if they rinse off the pad after using the clinell wipes.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: per the event additional information, it is stated: ¿this patient remains an in patient¿ did the patient remain ¿an in patient¿ due the burn? could you please confirm what is the severity of the burn? first degree burns are minor burns on the first layer of skin.Second degree burns have two types: superficial partial-thickness burns injure the first and second layers of skin.Deep partial-thickness burns injure deeper skin layers.Third degree burns injure all the skin layers and tissue under the skin.Are there any anticipated long-term effects from the burn? was the pad rinsed with water after cleaning and dried before use? was the cream that treated the burn doctor prescribed? are there any anticipated long-term effects from the burn? what is the current condition of the patient?.

Event Description

It was reported that during a lower anterior resection, a burn was discovered on the patient post operation.Electrosurgery burn on back of patient.No delay to surgery.

Manufacturer Narrative

(b)(4).Date sent: 6/18/2021.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.

Manufacturer Narrative

(b)(4).Date sent: 6/7/2021.Additional information received: received incident report.Mhra ref: 2021-005-004-401-606.See report under attachments.Additional information was requested, and the following was obtained: in the attachment it states ¿date of incident.Answer: (b)(6) 2021¿.The file states the incident was (b)(6) 2021.Please confirm what was the day of the procedure? answer: date of event was (b)(6) 2021, sales representative was not made aware of the complaint until (b)(6) 2021.

• Brand Name: MEGASOFT PEDIATRIC
• Type of Device: MEGA SOFT PEDIATRIC
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 11812202
• MDR Text Key: 250207846
• Report Number: 1721194-2021-00041
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103395
• UDI-Public: 10614559103395
• Combination Product (y/n): N
• PMA/PMN Number: K080741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2021

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: 0840
• Device Catalogue Number: 0840
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 05/18/2021; 06/18/2021
• Supplement Dates FDA Received: 06/07/2021; 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention