MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. RTN ELEC DUAL PLATE 9FT CORD; RETURN ELECTRODE DUAL PLATE WITH CORD

Model Number	0855CN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.What is the severity of the burn? (please see degrees of burns below and choose one): third degree burn, blackened.These were small, at monitoring needle sites.What medical intervention was used to treat the burn? (such as salve or stitches) unknown.Besides the burn, did the patient experience any adverse consequence due to the issue? none noted.Are there any anticipated long-term effects from the burn or injury? unknown.Rep had a neuro surgeon approached him about a burn.A photo was received of the foot that is in the file.Spinal procedure.Returned electrode on hamstring.This has happened on 4-5 different occasions.Generators have been in account since 2017.Patients in spine cases where nerve monitoring needles are placed in the legs and feet are exhibiting what looks like burns when the megadyne generators are used.Additionally, the nerve monitoring equipment is unreadable when the generator is simply ¿on¿, not even being activated.Generators are still being used.Burns can be on the lower leg and feet.Went over ifu during call.Needle electrode should not be used while using electrocautery.The rep will go over all ifu¿s with customer.Rep did not know room set up.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: how was the patient positioned? how was the room set up to include the megadyne generator vs.The other generators used in the procedure? does the surgeon believe there is there an alleged deficiency to the ethicon product that led to patient burn and if so why and on what product? what power levels was generator set to? 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.
Event or Problem Description
It was reported that during the posterior spinal fusion procedure, that during a c2-t4 posterior cervical fusion, nerve monitoring needles were placed in the patients shin, calf, and feet muscles, as well as the hands.At the completion of the procedure, perceived burn marks were noted on the patients feet and legs at the nerve monitoring needle sites.No burns were noted at the hands.The procedure was completed successfully.There were patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/5/2022.Photo analysis: this is an analysis of a set of images submitted to ethicon endo-surgery for evaluation.Image (4e53a566d852.Jpegaa): shows the bottom of the right foot.No particular issue is identified in the generator setting photo.Image (11b6746d37d1.Jpeg): shows locations of two stick pads in the lower part of the back thigh.Image (10530a18d658.Jpeg): photo label ended with d658 shows generator set up and energy level used.No particular issue is identified in the generator setting photo.In the photo with two stick pads on lower thigh areas, some wires are seen tangled on the right side.It is unsure if the locations of the stick pads and the tangled wire would contribute to alternative energy transfer to cause patient injury.In the right foot photo, two small blackened burn spots are visible on both lateral aspects of the middle foot.According to event description, they are corresponding to ¿the nerve monitoring needle sites¿.The burn injury is either deep second agree or third degree.Since there is a clear warning in the ifu to avoid using the nerve monitoring in the electrosurgical procedure if possible, the cause of the burn injuries are due to ifu being not properly followed.As part of the ethicon endo-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.

• Brand Name: RTN ELEC DUAL PLATE 9FT CORD
• Common Device Name: RETURN ELECTRODE DUAL PLATE WITH CORD
• 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: 14853198
• Report Number: 1721194-2022-00063
• Device Sequence Number: 4807934
• Product Code: GEI
• UDI-Device Identifier: 10614559104613
• UDI-Public: 10614559104613
• Combination Product (Y/N): N
• PMA/510(K) Number: K060255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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 Model Number: 0855CN
• Device Catalogue Number: 0855CN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown