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 Partial thickness (Second Degree) Burn (2694)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that during a liver transplant the bovi was activated outside of the patient and a spark jumped off the electrode and ignited a sponge.Attempting to douse the fire the surgeon burned her hand creating a blister.The sponge was thrown to the floor and doused with saline.There were no patient consequences.

Manufacturer Narrative

(b)(4).Only event year known: 2023.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: is the megen1 currently being used in the facility.If no, why not? yes.What is the serial number of the generator? unknown, rep trying to find out.Are there any photos of the burn that you could share with us in regards to the burn? no pictures available.If yes, please send to (b)(6).What is the severity of the burn? unknown.What medical intervention was used to treat the burn? unknown.Are there any anticipated long-term effects from the burn or injury? unknown.What is the current status of the surgeon? event took place on a saturday and rep was in a case with the surgeon on the following monday and she made no mention of the burn.In the surgeons opinion what was the contributing factor that caused the spark/fire? none, everyone seems to be confused as to how it happened.Does the surgeon believe there is there an alleged deficiency to the generator that led to the burn and if so why? unknown.What power levels was generator set to? set to 60 60.What was the end factor that was being used? was a megadyne probe but code is unknown.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: 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: 16428289
• MDR Text Key: 310131711
• Report Number: 1721194-2023-00047
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• 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
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention