MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGA 2000

Model Number	0800
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a tonsillectomy procedure, the patient had to return to the or due to re-bleeding.The bleeding occurred post op to the original procedure.An additional surgery was performed to stop the re-bleeding and the patient is recovering well.The account does not believe there has been any issue with the megadyne products in the re-bleeds.The account uses megapower generators, and all generators were pm¿d by the biomed and there were no issues with any of the generators.Typical setting on the generator are coag 10-15 up to 25.
Additional Manufacturer Narrative
(b)(4).Only event year known: 2022.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Additional information was requested, and the following was obtained: did the patient suffer any consequences due to the ¿re-bleed¿? if yes, what were the patient consequences? how much blood did the patient lose due to the ¿re-bleed¿? did the patient have to have a blood transfusion? how was the bleeding stopped? did the patient have to have any additional surgeries due to the ¿re-bleed?¿ did the original surgery have to be altered due to the ¿re-bleed¿ and if yes, how was the original surgery altered? what is the current status of the patient? answer= please see event description.To date there is no more information available.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: MEGA 2000
• Common Device Name: MEGA 2000
• 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: 16196707
• Report Number: 1721194-2023-00016
• Device Sequence Number: 4385948
• Product Code: GEI
• UDI-Device Identifier: 10614559100936
• UDI-Public: 10614559100936
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982826
• 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
• Report Date (Section B): 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 0800
• Device Catalogue Number: 0800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown