MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. RTN ELEC DUAL PLATE 15FT CORD; RETURN ELECTRODE DUAL PLATE 15 FT CORD

Catalog Number	0855CL
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a colostomy take down procedure that a dry sponge caught on fire after energy from the tip of the pencil "arc'd" towards the sponge during a procedure involving a megen1 and telescoping smoke pencil (10 ft).The dry sponge was reportedly 2 inches away from the tip of the pencil while activating.The brand of smoke evacuator was not reported on the call.The customer sent the megen1 to biomed for troubleshooting but they threw away the grounding pad and telescoping pencil.No patient consequence or procedure delay reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/28/2025.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.No lot or batch number was provided therefore a device history could not be done.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.

• Brand Name: RTN ELEC DUAL PLATE 15FT CORD
• Common Device Name: RETURN ELECTRODE DUAL PLATE 15 FT CORD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): NEW DEANTRONICS (US) LLC
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21719253
• Report Number: 1721194-2025-00038
• Device Sequence Number: 9492053
• Product Code: GEI
• UDI-Device Identifier: 10614559104019
• UDI-Public: 10614559104019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060255
• 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): 03/28/2025

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 Catalogue Number: 0855CL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown