MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGAPOWER 1000 A GENERATOR; MEGA POWER 1000 A, GENERATOR

Model Number 1000

Device Problem Arcing of Electrodes (2289)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 12/15/2022.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 received: mega power was put on the right side of patient.It was found that the device caught fire after a few minutes of use, and the extinguished fire.There was no harm to the patient and doctors.Gauze, gown and drape were partially burned.The output power was 30 for cutting/sealing, and 17 for bipolar.In order to fix the cord to the drape, the cord was wrapped in gauze, and clipped with forceps.The cord was not burned so the cause of fire is unknown.Covidien's reusable pencil for electric knife was used.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 an unknown procedure, it caught fire from cord of the electric knife when the electric knife was connected with generator.Surgeon¿s cloth was burned.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: MEGAPOWER 1000 A GENERATOR
• Type of Device: MEGA POWER 1000 A, GENERATOR
• 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: 15986844
• MDR Text Key: 308152650
• Report Number: 1721194-2022-00117
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559103715
• UDI-Public: 10614559103715
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000
• Device Catalogue Number: 1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2022
• 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