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

Catalog Number MEGEN1

Device Problem Self-Activation or Keying (1557)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported that the monopolar energy was repeatedly and inadvertently delivering energy from the megadyne (megen1) to the instrument in the model.The energy was delivered without pressing the pedal and without the option from the guick to activate energy, indicating some sort of bypass from the tower side as it delivered energy.No patient involvement.Steps to reproduce: insert monopolar energy cable into port a and into monopolar instrument.Insert bipolar energy cable to port b and into monopolar instrument.

Manufacturer Narrative

(b)(4).Date sent; 2/27/2024.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.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.A video was received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.Additional information received: the issue was observed during a ¿dry-run¿ test to ensure all relevant elements of planned test were functioning correctly.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: 4/12/2024.Additional information received: video analysis: according to video provided from the local r&d team to megadyne engineer a bipolar instrument was inserted in the monopolar b port of the megen1 generator ¿ as part of an engineering lab ¿dry run¿.The bipolar instrument was placed on top of a piece of wet linen and began to activate as soon as it encountered the wet (conductive) surface.Megadyne engineering team confirmed the bipolar instrument would activate when subjected to this specific scenario.Additional information received: were any of the associates trained in use of the megen1 generator or other electrosurgical equipment? response: no.Did the operator acknowledge the bipolar instrument should not be inserted/forced into the monopolar ports on the megen 1? response: no ¿ it was noticeably more difficult to insert the instrument plug into the monopolar b port, but it was achievable by deforming the plug pins on the connector.Are the associates aware of the two different plug geometries/configurations that differentiate monopolar devices from bipolar devices? response: no.Did anyone from the local team submit a product complaint for this issue? response: no, we documented the issue via jira comhw-5873.The most-recent comment in jira record references the dimensional differences between the monopolar and bipolar ports (3.2mm) [sic] and states the issue is attributable to user error.Is anyone from the local team trained on the franchise policy for complaint reporting? o response: not that we are aware of ¿ we are not responsible for reporting complaints.Sales rep reported that the monopolar energy was repeatedly and inadvertently delivering energy from the megadyne (megen1) to the instrument in the model.The energy was delivered without pressing the pedal and without the option from the gui to activate energy, indicating some sort of bypass from the tower side as it delivered energy.No patient involvement.Steps to reproduce: insert monopolar energy cable into port a and into monopolar instrument.Insert bipolar energy cable to port b and into monopolar instrument sales rep ethicon associate reported that the monopolar energy was repeatedly and inadvertently delivering energy from the megadyne (megen1) to the instrument in the model.The energy was delivered without pressing the pedal and without the option from the gui to activate energy, indicating some sort of bypass from the tower side as it delivered energy.No patient involvement.Steps to reproduce: insert monopolar energy cable into port a and into monopolar instrument.Insert bipolar energy cable to port b and into monopolar instrument.

Manufacturer Narrative

(b)(4).Date sent: 5/23/2024.Additional information received: the monopolar energy was repeatedly and inadvertently delivering energy from the megadyne to the instrument in the model.The energy was delivered without pressing the pedal and without the option from the gui to activate energy, indicating some sort of bypass from the ottava tower side as it delivered the energy.It was observed that the bipolar tool was plugged into the monopolar port.No patient involvement.

• 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: 18787614
• MDR Text Key: 337622970
• Report Number: 1721194-2024-00028
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559105597
• UDI-Public: 10614559105597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: MEGEN1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 05/22/2024
• Supplement Dates FDA Received: 04/12/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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