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

Catalog Number MEGEN1

Device Problems Arcing of Electrodes (2289); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/11/2023 b3: only event year known: 2023 video analysis: this is an analysis of a video submitted for evaluation.A video was provided by the customer.During the video, sparks could be seen during an unknown procedure, based on the video, the reported event was confirmed.No conclusion could be reached as to how this issue occurred through video analysis.No serial number was provided therefore a device history could not be done.Because the instrument was not returned our evaluation is limited.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: why does the surgeon believe there is an alleged deficiency to the device that led to patients bleeding and needed to be brought back to the or? what is the serial number of the generator? what was the procedure? can we please have the device returned for analysis? what were the settings on the generator? what was the handpiece that was being used? what was the mode of the generator set to (cut or coag)? what size vessels were trying to be coagulated? what was the clinical application that was being applied while the incident was occurring? how long has the account being using the megen1? what generator has been used in the past? 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.

Event Description

It was reported that during the unknown procedure the doctor expressed that the units are not acceptable and he has experienced excessive bleeding.He also states that small vessels spasm while he coagulates.He continues to complain of excessive sparks/arcs and is very unhappy with the generators.He mentioned that he had a bring back case due to excessive bleeding and that he feels that it was due to the generator.Unknown if the procedure was completed successfully or if there was any patient harm.

• 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: 17722869
• MDR Text Key: 323110975
• Report Number: 1721194-2023-00111
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MEGEN1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2023
• 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