MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGAPOWER 1000 A GENERATOR; MEGA POWER 1000 A, GENERATOR

Model Number	1000
Medical Device Problem Codes	Self-Activation or Keying (1557); Failure to Read Input Signal (1581); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure that the unit was cutting in and out on the bipolar then after testing it, it was found out that is was still doing it and that it was shooting way over the power limits.No patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/23/2023 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.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/5/2023.Investigation summary: per service manual operational and diagnostic analysis did not confirm the reported self activation issue, bipolar issue or excessive output.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.

• Brand Name: MEGAPOWER 1000 A GENERATOR
• Common Device Name: MEGA POWER 1000 A, GENERATOR
• 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: 16983200
• Report Number: 1721194-2023-00082
• Device Sequence Number: 20572094
• Product Code: GEI
• UDI-Device Identifier: 10614559103715
• UDI-Public: 10614559103715
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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 Model Number: 1000
• Device Catalogue Number: 1000
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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