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

Model Number 0845

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694)

Event Date 01/12/2023

Event Type  Injury  

Event Description

It was reported that during an adenoidectomy and myringotomy procedure the patient suffered surgical site burn involving megasoft pad model 0845.It was also reported that after checking the pad, staff noticed some area of the patient facing side (skin contact) was ribbed and gel exposed.There were multiple burn sites reported, patient was treated for the burns and plastic involved for consultation.Patient is stable and have since been discharged home.Pad and other equipment used have been removed from circulation.

Manufacturer Narrative

(b)(4).Date sent: 1/26/2023.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.Serial number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information received: megasoft pad is still being used at the facility.Burns first noticed at completion of procedure.2nd degree burn on elbow and back.Treatment of burn was plastics and famocine.The patient did not suffer any other adverse consequences besides the burn.Long term effects will be scaring.Current status of the patient is stable and discharged.The patient was positioned prone/ close to cable/ elbow close to back.The room set up was pad directly under with draw sheet.Nothing between the patient.The pad was not rinsed but was dry before procedure.Pad was cleaned with quad based cleaner.Does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? no, it was working as normal.No warming blanket used.It was not possible that the patient was in contact with any metal portion of the table.Erbe vio 300d generator was used sn (b)(4).Power levers were 50/60 (standard) classic 2/50.The end factor was a monopolar suction/cautery.No warming devices were used.No liquids used in prep no urine or other fluids detected in the field after surgery.No adjustment to setting.No diminish surgical interaction.Bovie scf10 disposable suction coagulator 10fr/footswitch.Additional information received: account has used 0845 for over 10 years now.Use them across 4 hospitals.30-40 pads in all.No change in the generator settings.The pad was completely connected to the generator.No liquids at all around the patient.Dry diapers on both patients after surgery.Only wearing diapers.Nothing else.Burns are on the outside of the diaper.Patient was sent home but will now need plastic surgery to help.Patient in prone position with back and elbow toward end of the pad where cable connects.Only a draw sheet between the patient and pad.The elbow and back were in direct contact with the pad.They are not rinsing or whipping the pad dry after putting the quad based cleaner on.No charring on the sheet.4 holes in the pad were a dime size.Initial treatment with topical cream.Not certain over long term burn care that the patient might need.No warming devices were being used.No certain if they used neck rolls.Metal mouth guard was being used which is standard procedure.The electrode was bovi 10 french using footswitch.The pad is out of service now and all megadyne pads are pulled on all sites.Not sure if the patient was moved during the procedure.The holes in the pad could possibly be from the cleaning from the facility.The pad is fairly new, and the pad could be breaking down.Patient position was supine (on patients back contacting megasoft pad).Additional information was requested, and the following was obtained: are there any photos of the burn that you could please share at (b)(4)? to be determined due to confidentiality what exact product is being used to clean the pad? to be determined, requested from customer.From a patient positioning and the elbow that was burned, was that elbow touching any part of the body? patient was supine and possible patients elbow was touching patients back.Was the burn located inside the diaper or outside of the diaper? reported outside the diaper.Q¿s: can you share photos of the burns as documented? are you able to confirm the exact product used to clean the pad and protocol? from a patient positioning, are you able to confirm if the patients elbow was contacting another part of the body? a¿s: 1.We do not take photos of the children¿¿there has to be consent for this.2.The exact product on the pad is attached in our standard work.3.The child¿s whole body was on the pad except their head).They were so tiny they did not take up the whole pad.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).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 determined that the 0845 pad was returned with a tear on the top surface near the corner overmold and discoloration.A functional test was performed on the pad, with a multimeter, and it pass the continuity test as intended.There were no related issues that could have caused the reported unintended thermal injury.It is possible that the damage noted on the returned sample could be possibly caused by exposing the pad to other equipment or may be a result of improper handling.The most likely cause of the discoloration 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.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device sn: (b)(6), and no non-conformances were identified.

Manufacturer Narrative

Pc-(b)(4).Date sent: 3/15/2023 investigation summary visual analysis of the returned sample determined that the 0845 pad was returned with a tear on the top surface near the corner overmold.Additional information provided: the sales team met with the customer again and next steps which included a call with the customer and the customer declined the call and meeting.H10 investigation summary.

Manufacturer Narrative

(b)(4).Date sent: 5/17/2023.

Manufacturer Narrative

(b)(4).Date sent: 5/11/2023.

Manufacturer Narrative

(b)(4).Date sent: 6/27/2023.Additional information received: it was found that the account was not rinsing the pad after cleaning the pad and the ifu was reviewed again.Spoke of the customer letter that ethicon sent out and specifically talked about how to properly clean and rinse the pad according to the ifu.Also the letter talked about the set up of the pad in accordance with the procedure.Reviewed the benchtop testing with animals labs and the extensive testing that was completed.

• 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: 16250361
• MDR Text Key: 308233697
• Report Number: 1721194-2023-00026
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103906
• UDI-Public: 10614559103906
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 2 YR
• Patient Sex: Female
• Patient Weight: 15 KG