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

Catalog Number	MEGEN1
Medical Device Problem Codes	Self-Activation or Keying (1557); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent 10/15/2024 d4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.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.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.Photo images photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.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 that during an unknown procedure the megen1 operate them self automatically when assembly the return electrode and pencil in port a.There was also an error105-12 after power the generator megen1 sn (b)(6).There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/12/2024.Investigation summary per service manual operational and diagnostic analysis confirmed the error code 105 and the self activation issue.The backplane pcb was replaced as identified in the investigation to address the both reported issues.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 repair and testing of the unit was completed.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.

• 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: 20449771
• Report Number: 1721194-2024-00080
• Device Sequence Number: 8559111
• Product Code: GEI
• UDI-Device Identifier: 10614559105597
• UDI-Public: 10614559105597
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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
• Report Date (Section B): 12/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: MEGEN1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 11/17/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/12/2024
• 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