MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. RTN ELEC DUAL PLATE 9FT CORD; RETURN ELECTRODE DUAL PLATE WITH CORD

Catalog Number	0855CN
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 3/25/2025.Mw5166185 and mw5166186.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: how was the procedure completed? after using the cold snare how was hemostasis achieved? was electrocautery utilized? was other return electrodes considered before changing to cold snare to include sticky pads? what model erbe generator 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 or Problem Description
Per user facility medwatch form, #mw5166185 and mw5166186, during an unknown procedure; the megadyne pad connected to erbe machine prior to a gi procedure requiring hot snare polyp removal.The erbe machine did not register the pad as connected.The pad was removed from patient and a new pad was applied to patient and again connected to erbe machine.The second pad applied did not register with the erbe machine.The provider had to convert the procedure to a cold snare.No patient harm was reported.Device was available for return.
Additional Manufacturer Narrative
(b)(4).Corrected data : b1, b2, h1.Additional information was requested, and the following was obtained: i know they converted the procedure to a cold snare.Because of this did the patient suffer any consequences? yes.If yes, what were the patient consequences? bleeding that required clips.What is the current status of the patient? no further follow up required as a result of this event why did the surgeon decide to convert to a cold snare? unable to use hot snare to remove polyp due to cautery pads not connecting to esu.How was the procedure completed? with cold snare removal of polyps.After using the cold snare how was hemostasis achieved? with clips.Was electrocautery utilized? unable to utilized due to failure of cautery pad connectivity with esu.Was other return electrodes considered before changing to cold snare to include sticky pads? the leg pad was changed three times with no success in using cautery.What model erbe generator was used? vio 200s.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: RTN ELEC DUAL PLATE 9FT CORD
• Common Device Name: RETURN ELECTRODE DUAL PLATE WITH CORD
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): NEW DEANTRONICS TAIWAN, LTD.
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21686917
• Report Number: 1721194-2025-00035
• Device Sequence Number: 13081807
• Product Code: GEI
• UDI-Device Identifier: 10614559104613
• UDI-Public: (01)10614559104613(17)270430(10)2201166N
• 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: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0855CN
• Device Lot Number: 2201166N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White