MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. 10FT SMOKE PENCIL UCONN; RETURN ELECTRODE CABLE, DUAL PLATE

Model Number	251010J
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Complete Loss of Power (4015)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 251010j device was returned with the smoke tube broken.In addition, an electrode tip was returned attached to the device.The device was connected to the generator and the device activates when the buttons were depressed.There were no issues on the device related to the event reported.It is possible that the damage to the tube lines could be due to an excessive pull and tubing stretched.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No lot or batch were provided, bhr could not be performed.Additional information was requested, and the following was obtained: what is the severity of the burn? (please see degrees of burns below and choose one) first degree burns are minor burns on the first layer of skin.The skin looks dry, redness, and may be swelling; no penetration or blisters second degree burn looks wet or moist.The burn site appears red, blistered, and may be swollen and painful third degree burn the burn site looks deep, whitening or blackened and charred what medical intervention was used to treat the burn? (such as salve or stitches) besides the burn, did the patient experience any adverse consequence due to the issue? are there any anticipated long-term effects from the burn or injury? answer = the burn was a first degree.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 or Problem Description
It was reported that during a low anterior resection procedure that while the device was laid down and not in use it self-activated burning through the surgeons gown and burning his arm.Unknown as to what degree of burn to the surgeons arm.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

• Brand Name: 10FT SMOKE PENCIL UCONN
• Common Device Name: 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: 16023848
• Report Number: 1721194-2022-00118
• Device Sequence Number: 6923074
• Product Code: GEI
• UDI-Device Identifier: 10614559105573
• UDI-Public: 10614559105573
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 251010J
• Device Catalogue Number: 251010J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown