MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ELECTROSURGICAL GENERATOR; INSTRUMENT, ULTRASONIC SURGIICAL

Model Number MEGEN1

Device Problem Arcing of Electrodes (2289)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

It was reported that during a video assisted thoracic procedure that in between two retractors surgeon was using a monopolar bovie and received small arching and flames while desiccating fatty tissue.Generator was removed and a competitor¿s generator was used to complete the procedure.There were no adverse consequences were reported.

Manufacturer Narrative

(b)(4).Date of event: unknown; captured as awareness date.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.A video was received and is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information received: surgeon experienced arcing between two s-retractors while activating bipolar instrument.The surgeon has attended two wet labs, one using the original generator, bovie pencil and tip.The other lab consisted of a different generator and our megadyne pencil and tip.Surgeon experience with the device is less than 6 months.(b)(6) started in servicing and started putting in the generators.No issues that week.The next week dr.(b)(6) was concerned with the level of arching and the proximity of the o2.35/35 is what the generator was set to.Previous generator was force fx and ft10.Dr.(b)(6) was concerned with arching as well and was concerned it was arching to the near by instruments.Any other issues were taken care of with additional training for surgeons.During the wet lab the generator was set to all different settings.35 for coag and using s retractors for the video.Coag 2 and 20 watts.The pencil that was used was medtronic pencil.Another wet lab was used with our pencil with our generator and dr.(b)(6) seemed pleased and it was not arching so much.But dr.(b)(6) was not happy with the level of arching.Dr.(b)(6) operates in a tighter surgical area.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: 2/16/2023.A manufacturing record evaluation was performed for the finished device serial number, and no non-conformances were identified.Video analysis: this is an analysis of the video submitted for evaluation.Video: the video provided by the customer shows a monopolar bovie being tested on a piece of meat, during the activation the device is arcing with an instrument that is used to separate de the meat.It is possible that the arcing to the metal retractor appears to occur when they are not in close proximity to the tissue.The event described could not be confirmed as no detectable damage could be observed.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 observed during the photo analysis.Because the instrument was not returned our evaluation is limited.

Manufacturer Narrative

(b)(4).Date sent: 2/23/2023.Investigation summary: per service manual operational and diagnostic analysis did not confirm the reported arching or flames.The unit passed all functional tests and is fully operational.No further investigation will be conducted on this complaint.

• Brand Name: ELECTROSURGICAL GENERATOR
• Type of Device: INSTRUMENT, ULTRASONIC SURGIICAL
• 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: 16252495
• MDR Text Key: 308964810
• Report Number: 1721194-2023-00028
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559105597
• UDI-Public: 10614559105597
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEGEN1
• Device Catalogue Number: MEGEN1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1