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

Catalog Number MEGEN1

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

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

Event Date 11/30/2023

Event Type  Injury  

Event Description

It was reported that during an ent procedure the patient got burns while using our megen1.Earthing checked and it was perfect.Dr.Was using other company's disposables like cautery pencil and pad.The surgery was delayed 15 minutes.The procedure was successfully completed.

Manufacturer Narrative

(b)(4).Date sent; 12/14/2023.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.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 was requested, and the following was obtained: is the megadyne pad currently being used in the facility.· if no, why not? yes.Are there any photos of the burn (s) that you could share with us in regards to the burn? · if yes, please send to (b)(6).Didn't take photos is there any damage(s) noted on the pad? · if yes, where are they and what is the description of the damage(s)? it was new pad and they are not reusing pads.Are there photos that can be shared of the pad? · if yes, please send to (b)(6).No.They have disposed.How long has the account been using mega soft? about 1 year, not only megasoft but using other company pads too.Does the surgeon believe there is an alleged deficiency to the pad that led to patient burn and if so why? pad used was new one and it does not have any damages.When were the burns first noticed? very next day after the case.What is the severity of the burn? (please see degrees of burns below and choose one) second degree.What medical intervention was used to treat the burn (such as salve or stitches)? as per the protocol where is the burn located on the patient? back side of shoulder was the reported issue at the pad site or alternate site? alternate 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 is the current status of the patient? still at hospital under treatment what was the surgical procedure? head and neck procedure how long did the surgical procedure last? 8-9hrs was the pad rinsed with water and let dry before this surgical procedure? sticky pad used and there was no water 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? pad fixed on thigh was there anything between patient and the pad (ex.Sheet, drape, etc.)? no were there liquids used in prep? no was urine or other fluids detected in the field after surgery? no was there any patient warming blankets used? · if yes, what warming device and/or blankets were used and what is the location in relation to the patient? no what temperature setting was used on the warming device(s)? na what generator was being used? megen1 what power levels was generator set to? 35 35 35 was there any diminished effect of the generator noted during the surgery? no what monopolar disposables were used during the procedure? covedien what is the age of the patient? if the age of the patient is not known, is the patient an adult or pediatric patient? adult what ethnicity is the patient? indian what is the serial number of the pad? : do not know the serial no.As they disposes the same day.What cleaner or disinfectant (brand name or active ingredients) was used to clean the pad? : microshield tincture(chlorhexidine and ethanol solution) what skin preparation regiment was utilized for the procedure? : could you please elaborate about the above question ? 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: in the additional information it stated ¿what medical intervention was used to treat the burn (such as salve or stitches)? as per the protocol¿.Please give more detail about what exactly was done to treat the patients 2nd degree burn.What was the product code of the sticky pad? was the burn in the sticky pad area or under the pad area or was it an alternate site? where was the sticky pad located in reference to the burn? does the surgeon believe there is an alleged deficiency to the generator that led to the patient burn and if so way? 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: 1/18/2024.Additional information was requested, and the following was obtained: in the additional information it stated ¿what medical intervention was used to treat the burn (such as salve or stitches)? as per the protocol¿.Please give more detail about what exactly was done to treat the patients 2nd degree burn.They have cleaned with cotton and put silverex ointment and dressed the burned area.What was the product code of the sticky pad? they did not check the sticky pad code as it is a disposable so they discarded after the case.Was the burn in the sticky pad area or under the pad area or was it an alternate site? it seems alternate site.Where was the sticky pad located in reference to the burn? sticky pad located on thigh.Does the surgeon believe there is an alleged deficiency to the generator that led to the patient burn and if so way? they believes that it happened due to generator.They are not reusing cautery pads.

Manufacturer Narrative

(b)(4).Date sent 2/28/2024 investigation summary per service manual operational and diagnostic analysis identified an issue when analyzing the megen1.The rf amplifier pcb and power pcb were replaced as identified in the investigation to address the issue.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.The repair and testing of the unit was completed.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.

• Brand Name: ELECTROSURGICAL GENERATOR
• 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: 18324230
• MDR Text Key: 330479925
• Report Number: 1721194-2023-00139
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559105597
• UDI-Public: 10614559105597
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K193145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MEGEN1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization