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

Model Number 004025

Device Problems Arcing of Electrodes (2289); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/01/2022

Event Type  Injury  

Event 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.

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.

• Brand Name: SUCTION COAGULATOR FTSW 10FR
• Type of Device: 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: 16245790
• MDR Text Key: 308157153
• Report Number: 1721194-2023-00024
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559105139
• UDI-Public: 10614559105139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 004025
• Device Catalogue Number: 004025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention