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

Catalog Number	MEGEN1
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/9/2024.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.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 during an unknown procedure when using bipolar auto mode, the generator is activating constantly.Happened first in ot and then re-created post op no patient involvement.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/17/2024 the device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent 2/4/2025 additional information was requested, and the following was obtained: what accessory was used? what software version is used? what was the length of the cable? response: no further information available.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/21/2025.Investigation summary per service manual operational and diagnostic analysis did not confirm the reported bipolar auto mode was constantly activating.The unit passed all functional tests and is fully operational.No further investigation will be conducted on this complaint.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 Manufacturer Narrative
(b)(4).Date sent: 3/7/2025.Investigation summary : service center unable to replicate issue experienced.However during final test before returning to customer, service center has detected defects.- unit failed footswitch supply check.Multimeter reading only at 11.98 vdc - unit was then checked for differences in output between handswitch and footswitch activation.It was found that in bipolar mode, handswitch activation is weaker than footswitch activation.The weaker output is not within specified ranges.Customer is quoted backplane pcb replacement.Customer has rejected quote.

• 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: 20878141
• Report Number: 1721194-2024-00096
• Device Sequence Number: 7832035
• Product Code: GEI
• UDI-Device Identifier: 10614559105597
• UDI-Public: (01)10614559105597(11)200604
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/07/2025

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
• Device Lot Number: 203701001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 01/31/2025; 02/21/2025; 03/07/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/17/2024; 02/04/2025; 02/21/2025; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown