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

Catalog Number	MEGEN1
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a plastics case, a lap pad fire that was quickly extinguished and that there was no harm to the patient or staff.
Additional Manufacturer Narrative
(b)(4).Date sent 2/11/2025.Investigation summary: per service manual operational and diagnostic analysis did not confirm the reported flame/flash/fire issue.Additionally, the backplane pcb was repaired.The repair of the backplane pcb component was unrelated to the reported issue.The unit passed all functional tests and is fully operational.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.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.Additional information received: (b)(6) 2023 the generators went into the account.15 generators went into the ent space.Next was ortho and plastics dept.Those generators have been there 4-5 months.In the last 3 months about 20 surgeons have had issues with the generator.The main complaint is with bipolar.Not working or not providing enough energy.On (b)(6) there was a fire for a plastic surgery.The generator was pulled and sent to cincy.The resident activated pencil on a dry lap pad and activated for a long period of time.This issue is being dealt with internally.Education has been happening with surgeons.No error codes.Not using megadyne cables.Software on the generators have not been done.Standard bipolar is being used not standard bipolar.Generator power settings, not sure what they are set at.Sticky pad was used.No one knows if the pad was being pulled off during the case.The log control showed the settings at 60 micro.Cqm looks okay does not look like the pad was pulling off.Product code for the disposable was devices in-use during case (found in medical record): (b)(6): megen1 bovie generator (b)(6)): pencil hand switch w/ button (b)(6): bovie electrode (b)(6): grounding pad / return electrode (b)(6): surgical smoke evacuation pencil (b)(6): cautery tip cleaner pad.The rep is not in the or when the issue happened.During this event, an ethicon megadyne esu generator & ez-clean electrode were in use.A different brand of pencil was in use.Additional information was requested, and the following was obtained: what was the procedure? panniculectomy - where did the fire occur? on the belly by the abdominal flap near the middle of the abdomen.- how long was the fire? single flame that lasted a second or two.- monopolar or bipolar being used when fire occurred? settings? monopolar and 40/40 - was the sticky pad or bovie pencil inspected after fire? surgeon does not think so.- other comments? surgeon feels megen1 are unsafe.Have had bovie arching in most cases using new machines.She says it looks like a lightning bolt each time and she has no control where it¿s going.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: what was the issue with the megen1? does the surgeon believe the megen1 caused the fire on the lap 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.
Additional Manufacturer Narrative
(b)(4), date sent: 2/13/2025.Additional information received: megen1 have been removed from all the plastic, ortho and some of the surgeon rooms for patient safety.Surgeons are seeing too many bovie arching and bipolar issues.There was a lap pad that started a fire in the or.During the review at the hospital the energy level of the generator had to be increased and arching.The mode the generator was set at coag 1 monopoloar.Power setting of 40.The account is used to force triad generator.Neruo/ ent/ spine has been using megn1 9-10 months.Plastics have been using 3-4 months.All disposables have been the same between any generators.Similar mode was selected in the generators.0824 surgery start 0905 time event reported to have occurred ¿ generator continued to be used 1145 surgery end.Additionally, the generator remained in circulation until 1/10 when it was removed to be analyzed.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/27/2025.Investigation summary: based on our analysis of the megen1 activation log, there are several activations that indicate the surgeon activating away from tissue.Two of these activations, bolded in the review below, have characteristics of arcing while activating away from tissue.The output power remained below the generator¿s power setting, demonstrating safe and effective power control.8:26:44 am to 8:48:37am: start of surgery.Return electrode is attached and cqm reading is nominal.Two micro bipolar auto activations, power setting 60 watts.Very short (10s of milliseconds) with minimal power delivery.Single pure cut activation, power setting 40 watts.0.784 seconds in length and 14 watts power output.8:48:37am to 9:02:14 am: 146 coag 1 activations, power setting 40 watts.Activation times vary but are all a few seconds or less.Most activations have an output of 20 to 25 watts.Several activations that delivered lower power (7 and 2 watts), possibly indicative of activating away from tissue.Notable activation at 8:57:54 am with an output power of approximately 39 watts.Activation length was 0.931 seconds.This activation is indicative of arcing due to the output power being near the power setting of 40 watts, while most activations had output power around 20 watts.9:02:55am: single pure cut activation, power setting 40 watts.0.370 seconds in length, output of approximately 17 watts.9:03:06 am to 9:08:23am ¿ fire occurred at approximately 9:05am.45 coag 1 activations, power setting 40 watts.Generally consistent with the group of 146 coag 1 activations listed above.Notable activation at 9:06:30 am with a power of output of 38 watts.This activation is indicative of arcing due to the output power being near the power setting of 40 watts, while most activations had output power around 20 watts.9:08:40 am to 11:44:07 am: the remainder of the surgery activations are in line with the nominal activations mentioned above.Note: coag 1 power crest factor is estimated to be 20 based on tissue testing.Pure cut power crest factor is estimated to be 2.5 based on values from the ifu.Note: the time stamps may be several minutes off due to time drift.

• Brand Name: ELECTROSURGICAL GENERATOR
• Common Device Name: 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 ; 3035526892
• MDR Report Key: 21357981
• Report Number: 1721194-2025-00016
• Device Sequence Number: 15562893
• Product Code: GEI
• UDI-Device Identifier: 10614559105597
• UDI-Public: (01)10614559105597(11)230728
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193145
• 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,Followup
• Report Date (Section B): 02/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MEGEN1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/11/2025; 02/26/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 02/13/2025; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown