MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. ELECTROSURGICAL GENERATOR; INSTRUMENT, ULTRASONIC SURGIICAL

Model Number MEGEN1

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

Patient Problem Burn(s) (1757)

Event Date 03/13/2023

Event Type  Injury  

Event Description

It was reported that during a pacemaker procedure that while working near the patients clavicle using the monopolar mode when the oxygen from the patient's mask ignited and breathed into the patient's lungs.Unknown if the patient's mask was leaking oxygen or not.Patient was discharged 24hrs post-op and is doing ok.

Manufacturer Narrative

(b)(4).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.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.Additional information was requested, and the following was obtained: was there any patient consequence? burns to the lungs if so, was any treatment administered? unknown.Patient was transferred to the burn unit.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what does the operating surgeon believe to be the alleged deficiency of the megadyne devices used in the procedure?.What end effector was used?.Was any sparking or arcing seen in the procedure?.Was the patient¿s post-op care altered in any way due the issue?.Was there any medical or surgical intervention for the burns to the lungs?.What was the proximity of the end effector activation to the source of the oxygen?.

• Brand Name: ELECTROSURGICAL GENERATOR
• Type of Device: INSTRUMENT, ULTRASONIC SURGIICAL
• 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: 16635477
• MDR Text Key: 312230606
• Report Number: 1721194-2023-00057
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559105597
• UDI-Public: 10614559105597
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/29/2023

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
• Device Operator: Health Professional
• Device Model Number: MEGEN1
• Device Catalogue Number: MEGEN1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention