MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. 15FT SMOKE PENCIL UCONN; RETURN ELECTRODE CABLE, DUAL PLATE

Model Number 251015J

Device Problems Flaked (1246); Appropriate Term/Code Not Available (3191)

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

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

(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? concomitant product: (b)(4).Unknown sponge.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 a lap band removal due to gastric necrosis procedure while activating the pencil made a ¿pop¿ sound and then a flash of flame was seen that extinguished on its own 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 not further issue.There were no error codes reported on the generator.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Date sent: 12/6/2022.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.Additional information was requested, and the following was obtained: were there any patient consequences? if yes, what were the patient consequences? no patient consequence.

Manufacturer Narrative

(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.

• Brand Name: 15FT SMOKE PENCIL UCONN
• Type of Device: RETURN ELECTRODE CABLE, DUAL PLATE
• 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: 15834199
• MDR Text Key: 307882910
• Report Number: 1721194-2022-00110
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10614559105580
• UDI-Public: 10614559105580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 251015J
• Device Catalogue Number: 251015J
• Device Lot Number: 2009170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1