MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. RTN ELEC PEDIATRIC DUAL 9FT CD; RETURN ELECTRODE PEDIATRIC

Model Number	0865C
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during external genital procedure, the surgical field was a tightly defining area to be operated.Two burn-like lesions were discovered when removing of the fields.It were similar in size and shape to the tip of the electric scalpel, under the fields, at a length from the operating site, on the inner side of the thigh and the iliac wing.The lesions were covered by skin glue.Estimated burn grade 2 superficial.The lesions will be scarred, which may produce skin marks.
Additional Manufacturer Narrative
(b)(4).Additional information provided: other competitive product: erbe medical electric scalpel.Vio 3 4 sorties: bi, mono, mf, mf-u identifie: 8.Reference: (b)(4).Lot number: 11502281.Other competitive product: (b)(4) intco industries co ltd.Electric scalpel (electrode/handle).Disposable electrosurgical pencil.Controle graphique.Reference: (b)(4).Lot number: 16679.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: will the device be returning for analysis? are there any photos of the burn that you could share with us in regards to the burn? if yes, please send to (b)(4).What medical intervention was used to treat the burn? (such as salve or stitches) besides the burn, did the patient experience any adverse consequence due to the issue? what is the current status of the patient? how was the patient positioned? how was the room set up to include patient set up and where was the pad in relation to the patient? does the surgeon believe there is there an alleged deficiency to the pad that led to patient burn and if so why? where was the return electrode placed? how close was the return electrode to the surgical site? was the burn located under the return electrode? where is the burn located? are the burns close by each other or far apart? where was the electrode pencil placed when not in use? was a holster used for the electrode pencil?.
Additional Manufacturer Narrative
(b)(4).Date sent: 6-13-2022.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/9/2022.Photo analysis: this is an analysis of a set of images submitted to ethicon endo-surgery for evaluation.Image: this one photo looks like from a toddle, showing two separate skin lesions located at the right iliac wing and inner side of the right thigh.Both lesions appear as redness.The top one is dry with no skin swollen or blister visible while the lesion in the inner thigh is wet with blister.The skin lesions is likely first to second degree of burn injury.Since the size and shape of the skin burn appear to be consistent with tip of electric scalpel used in the procedure, the likely cause of the burn injury is due to user handling.As part of the ethicon endo information surgery quality process all devices are manufactured, inspected, and released to approved specifications.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information was requested, and the following was obtained: are there any photos of the burn that you could share with us in regards to the burn? yes.What medical intervention was used to treat the burn? (such as salve or stitches) surgical glue.Besides the burn, did the patient experience any adverse consequence due to the issue? no.What is the current status of the patient? cured.How was the patient positioned? on the back.How was the room set up to include patient set up and where was the pad in relation to the patient? unk.Does the surgeon believe there is there an alleged deficiency to the pad that led to patient burn and if so why? unk.Where was the return electrode placed? sacred position.How close was the return electrode to the surgical site? surgical site pubis, 1 year old child.10, 20 cm ? was the burn located under the return electrode? no.Where is the burn located? are the burns close by each other or far apart? 2 burns.Where was the electrode pencil placed when not in use? unk.Was a holster used for the electrode pencil? unk.How was the room set up to include patient set up and where was the pad in relation to the patient?room set up as usual.The position is no longer known precisely, probably lumbar or posterior thigh.Does the surgeon believe there is there an alleged deficiency to the pad that led to patient burn and if so why? no.The surgeon does not think.Where was the return electrode placed? put down on the field, as usual.Was a holster used for the electrode pencil? no.Upon review of the additional information the surgeon has indicated that the device did not contribute or cause the complications and that there was no deficiency with the 0865c used in the procedure.Based on available evidence the issue may have resulted in user handling of the hand held device that is not ethicon related.This file is no longer a us fda serious injury file.

• Brand Name: RTN ELEC PEDIATRIC DUAL 9FT CD
• Common Device Name: RETURN ELECTRODE PEDIATRIC
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): NEW DEANTRONICS TAIWAN, LTD.
• Manufacturer Contact: orla o'mahony ; 11506 south state street; draper 84020
• MDR Report Key: 14345325
• Report Number: 1721194-2022-00033
• Device Sequence Number: 12316592
• Product Code: GEI
• UDI-Device Identifier: 10614559102770
• UDI-Public: 10614559102770
• Combination Product (Y/N): N
• PMA/510(K) Number: K071080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 0865C
• Device Catalogue Number: 0865C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 05/23/2022; 06/08/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/09/2022; 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 YR
• Patient Sex: Unknown