MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. SUCTION COAGULATOR FTSW 10FR; SUCTION COAGULATOR FOOTSWITCHING 10 FR

Model Number	004025
Medical Device Problem Codes	Arcing of Electrodes (2289); Adverse Event Without Identified Device or Use Problem (2993)
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.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 exact lot number is unknown.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.The 004025 requires and adapter and the account uses valley lab adaptors.To date there is no more information available.
Additional Manufacturer Narrative
(b)(4).Only event year known: 2022.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 004025 device was returned with no apparent damage.The device was tested for suction and continuity and worked as intended.No anomalies were observed with the functionality of the device.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.The exact lot number that was used in the procedure is unknown.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete 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).D4.The exact lot number is unknown.

• Brand Name: SUCTION COAGULATOR FTSW 10FR
• Common Device Name: SUCTION COAGULATOR FOOTSWITCHING 10 FR
• 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: 16245684
• Report Number: 1721194-2023-00019
• Device Sequence Number: 15055072
• Product Code: GEI
• UDI-Device Identifier: 10614559105139
• UDI-Public: 10614559105139
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072559
• 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): 01/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 004025
• Device Catalogue Number: 004025
• Device Lot Number: SM2208026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown