MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT UNIVERSAL PLUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 0847

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

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 10/18/2023

Event Type  Injury  

Event Description

It was reported that during a pediatric tonsillectomy the patient experienced a significant burn on their right hip.No other information is available.

Manufacturer Narrative

(b)(4).Date sent: 11/30/2023.Investigation summary.The product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned samples revealed that the 0847 pad and cables were returned with no apparent damage.The pad and cables were connected to the generator, and no anomalies were observed.The electrical test was performed and it meets the specifications.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.A manufacturing record evaluation was performed for the finished device batch gs22028706, and no non-conformances were identified.Additional information received: i went to the hospital hours after the incident was communicated to me to try and gather as much information as possible.Risk management took the lead right away so i was not allowed to speak with the staff in the room to gather more information.I spoke to the anesthesiologists that was in the case but she didn¿t notice the positioning of items like a mayo stand or iv pole that could have contributed to the incident.The patient was a 5yr old and it occurred during a tonsillectomy.The boy kept his boxer shorts on for the procedure but the burn wasn¿t noticed on the patient until he was about to be discharged home.He told his mom that his hip area was hurting and that¿s when they noticed the burn.I looked at the pad and it didn¿t appear to have any rips or tears in it.I called in the incident and took the pad with me to be shipped back for investigation.The next day the account asked me to bring it back so the biomed team to conduct more testing.The shipper kit will deliver to me today and i will check with the account today to see if all testing has been completed so i can ship it back.Have you been in surgery with this customer since this report to better understand this issue? (y/n) yes but i was not allowed to speak with the team that was present in the or during the incident.I was told to communicate with risk management going forward.Surgeon experience with the device? unknown at this time.We have not involved any commercial leaders up to this point.Immediately after the incident occurred, the hospital started their own investigation into the equipment that was used in the or that day to see if they could identify any issues.Or leadership has deferred to risk management going forward.The account has photos of the incident so we¿ll have to wait to see if they are willing to release the photos to us.One of the reps was at the hospital a few hours after the incident happened.He asked to speak with the staff who were in the room during the procedure but was denied.The rep did talk with the nurse manager who said that the burn was on his right hip (not on the butt cheek but on the side).The patient did still have boxer shorts on.The surgeons worked on his tonsils on this left side.So, there was no equipment on the right side.The rep also talked to the anesthesiologist who showed the rep a picture of the burn.The rep provided a description of the burn: it was a darker color than red, and it was 3-4 inches long and 1.5-2 inches wide.The anesthesiologist did indicate that the photo did not show how much the burn had blistered, which occurred after the photo was taken.The burn looked it would be covered the boxer shorts and would be lower than the waist band if the boxer shorts were placed at the waist.The burn wasn¿t noticed until discharge when the patient mentioned pain on his hip and his mom discovered it.No one would say if there was any treatment for the burn.The rep indicated that the facility uses a chuck pad over top of the megasoft pad.He also indicated that they use a cleaning agent that is on the approved list.It is unknown if they are rinsing and drying the pad prior to use.The rep indicated the hospital team was very receptive with the education and cleaning tip of the pad.The facility had used the megasoft pad previously but stopped in 2017 due to a cleaning product change.They started reusing the pad in (b)(6).In replying to questions the rep does not know if the procedure included adenoid removal or not and he is assuming the patient was laying supine, but he will verify.The rep also did not know if the patient was in direct contact with the megasoft pad.The hospital¿s biomed team did test the equipment from the surgical room that was used in the procedure after it the burn was discovered.The rep did indicate that the or manager does want to work with us in the investigation, but the risk management team is in the lead.This was a pediatric patient.The patient was a 5yr old and it occurred during a tonsillectomy.The boy kept his boxer shorts on for the procedure but the burn wasn¿t noticed on the patient until he was about to be discharged home.He told his mom that his hip area was hurting and that¿s when they noticed the burn.Additional information was requested, and the following was obtained: is the megadyne pad currently being used in the facility.The pads are no longer being used while we are investigating this incident.They were all pulled as of 10/18/23.2.Are there any photos of the burn (s) that you could share with us in regard to the burn? burn is to left lateral hip: 3.Is there any damage(s) noted on the pad? none readily visible.If yes, where are they and what is the description of the damage(s)? 4.Are there photos that can be shared of the pad? pad has been returned to vendor.5.See photo for serial number.6.How long has the account been using mega soft? since approximately 2014.Stopped using them at some point and then went back to them due to a shortage of the disposable pads during covid.Started using them again in 2021.7.Does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? yes, it is believed the burn was related to the pad due to no other explanation for the burn and the knowledge that other such burns have occurred per the 2023 medical device correction sent out by megadyne.8.When were the burns first noticed? when the patient began waking in post-op and complained of pain to his left hip area.9.What is the severity of the burn? (please see degrees of burns below and choose one) between second and third degree burn.Burn description by wound care staff: 10.What medical intervention was used to treat the burn (such as salve or stitches)? daily treatment with santyl and allevyn.11.Where is the burn located on the patient? left lateral hip.12.Was the reported issue at the pad site or alternate site? at the pad site.Pad is full bed pad so the patient¿s entire body was on the pad.13.Besides the burn, did the patient experience any adverse consequence due to the issue? he was kept overnight to manage his pain and had to be seen in our wound care clinic to establish wound care process.14.Are there any anticipated long-term effects from the burn or injury? unknown at this time.15.What is the current status of the patient? patient is continuing to do daily dressing changes.Wound healing will likely take another 4-6 weeks.16.What was the surgical procedure? adenoidectomy, bilateral tympanostomy tube placement 17.What was the surgical procedure date? 10/18/23 18.How long did the surgical procedure last? approximately 90 minutes.19.What cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? virex ii 256.20.Was the pad rinsed with water and let dry before this surgical procedure? yes.21.How was the patient positioned? supine with head on shoulder roll, head turned 90¿ to his right.22.Is it possible the patient was in contact with a metal portion of the or table? no.23.How was the room set up to include patient set up and where was the pad in relation to the patient? there was a mayo stand on the right side of the bed, the surgeon was at the head and the anesthesiologist to the left.Pad was underneath the patient, full body.24.Was there anything between patient and the pad (ex.Sheet, drape, etc.)? there was a thin sheet between the patient and the pad.25.Were there liquids used in prep? no.26.What skin preparation regiment was utilized for the procedure? none.27.Was urine or other fluids detected in the field after surgery? no.28.Was there any patient warming blankets used? no.29.What temperature setting was used on the warming device(s)? 30.What generator was being used? none.31.What power levels was generator set to? 32.Was there any diminished effect of the generator noted during the surgery? 33.What monopolar disposables were used during the procedure? coviden 10 french suction bovie.34.What is the age of the patient? 5 years old.35.What ethnicity is the patient? hispanic.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.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: additional information stated, ¿pad is full bed pad so the patient¿s entire body was on the pad.¿ was the pad the megasoft pad? the megasoft pad does not cover the entire bed.Where the blister occurred was that on a green 0847 megasoft pad in direct contact with that pad? the additional information stated ¿supine with head on shoulder roll, head turned 90¿ to his right.¿ was the patient on their back? was the hip in contact with the 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).Date sent: 12/11/2023.

Manufacturer Narrative

(b)(4).Date sent: 12/7/2023.Additional information was requested, and the following was obtained: for the size of the bed pad, you are of course correct it does not cover the entirety of the bed but what is more accurate is it covered nearly the length of this particular child.It was at least under his entire torso down to his knees or so.He was on his back (supine) for the surgery and the area of the burn was in contact with the pad.It was mid-buttock and slightly closer to the hip bone side of his body than the gluteal fold side, if that makes sense.Left lateral hip burn.Patient lying supine, cloth underwear, nothing leaning on patient, nothing leaning on patient.30 coag for generator.Valleylab generator force fx.Standard or table.The hip and burn area was on the pad.Visual inspection, looking for any damage.No obvious sign of any damage.Also, a functional test was completed.This pad passed this test as well.Also checked electrical continuity.The pad passed all test.

• Brand Name: MEGASOFT UNIVERSAL PLUS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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 ; PR ; 3035526892
• MDR Report Key: 18237198
• MDR Text Key: 329368440
• Report Number: 1721194-2023-00134
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559104842
• UDI-Public: 10614559104842
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2023

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 Catalogue Number: 0847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/01/2023; 12/11/2023
• Supplement Dates FDA Received: 12/07/2023; 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• 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-1999-2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic