MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT DUAL; MEGA SOFT DUAL

Catalog Number	0835
Medical Device Problem Code	Arcing of Electrodes (2289)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/10/2025.B3: only event year known: 2025.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.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.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 an unknown while using an electrocautery pencil, the electricity arced to the surgeons hand holding a laparotomy sponge.The arc caused the sponge to light on fire and initially the surgeon thought her glove may have had a hole but there was no indication of a burn or injury to her finger.The surgeon believed the megasoft pad to be the cause so they continued the case using a sticky pad and had no further issues.Upon inspection, the megasoft pad did not appear to have any damage, burns, or other issues and the patient did not suffer any injuries either.The surgery was delayed 15 minutes.The procedure was successfully completed.There were no patient consequences.Fire was put out and a sticky pad was used.,.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/10/2025.

• Brand Name: MEGASOFT DUAL
• Common Device Name: MEGA SOFT DUAL
• 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: 21343128
• Report Number: 1721194-2025-00015
• Device Sequence Number: 9078781
• Product Code: GEI
• UDI-Device Identifier: 10614559101872
• UDI-Public: (01)10614559101872(17)250331
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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 Expiration Date: 03/31/2025
• Device Catalogue Number: 0835
• Device Lot Number: GS23001914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1996-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown