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

Catalog Number	MEGEN1
Medical Device Problem Codes	Self-Activation or Keying (1557); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, when the automatic bipolar mode is activated, it activates without bringing it close to the tissue and generates a detection sound.No patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/19/2026.D4 batch #: unknown.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.Investigation summary: per service manual operational and diagnostic analysis did not confirm the reported self activation or the bipolar issue.However, during testing an error 105 and error 107 were observed.The backplane pcb was replaced to address both errors.The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality.The unit passed all functional tests and is fully operational.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.

• Brand Name: MEGADYNE
• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 25217138
• Report Number: 1721194-2026-00023
• Device Sequence Number: 9801471
• Product Code: GEI
• UDI-Device Identifier: 10614559105597
• UDI-Public: 10614559105597
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 05/19/2026

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: 04/27/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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