MEGADYNE MEDICAL PRODUCTS, INC. 15FT SMOKE PENCIL UCONN; RETURN ELECTRODE CABLE, DUAL PLATE
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Model Number 251015J |
Device Problems
Flaked (1246); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a lap band removal due to gastric necrosis procedure that while activating the bovie pencil the pencil made a ¿pop¿ sound then there was a flame which ignited the sponge that was nearby.Fire was extinguished with no harm to the patient.The sticky pad was then removed and replaced, and surgeon then switched to harmonic to continue with a portion of the case.Surgeon then later went back to using the bovie with no further issue.There were no error codes reported on the generator.There were no adverse consequences for the patient.
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Manufacturer Narrative
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(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: were there any patient consequences? if yes, what were the patient consequences? 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.
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Manufacturer Narrative
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(b)(4).Date sent: 12/21/2022 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 251015j device was received with the nozzle crack.The device was tested with the generator and it performed as expected.There was no flash flame fire at any time during the test.The ifu states the following warning: electrosurgical active electrodes may remain hot enough to cause a fire or burn during use or shortly after the rf current is deactivated.Do not place them near or in contact with flammable materials and substances (e.G.Drapes, gauze, endotracheal tubes, etc.).Devices that are activated or hot from use may cause a fire.No conclusion could be reached as to how the nozzle got cracked.As part of the ethicon endo-surgery quality process, all devices are manufactured, inspected, and released to approved specifications.
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Manufacturer Narrative
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(b)(4).Date sent: 12/6/2022.Additional information was requested, and the following was obtained: were there any patient consequences? if yes, what were the patient consequences? no patient consequence.
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Manufacturer Narrative
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(b)(4).Date sent: 1/10/2023.Additional information was requested, and the following was obtained: what were the generator settings? unknown, based of pref cards it should have been blend 40 and coag 1 40.
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Search Alerts/Recalls
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