MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGASOFT UNIVERSAL PLUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0847
Medical Device Problem Codes	Arcing of Electrodes (2289); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/15/2024.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.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.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.Serial number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information received: we had a operating room fire with a patient on the table.We have no idea why.We have checked all of our equipment and see no issues but looks like coming from pad, there is a connector cord that goes in pad to connecting cable to the generator, and it is all chard.They stated they have not identified any patient harm at this time.They stated this happened during the case.Anything look different with cord and pad than normal? no.They stated they did their own analysis from clinical team and biomed on the generator and connectors but see no issues.Additional information was requested, and the following was obtained: did the pad (0847) catch on fire? yes.Did the connector cords catch on fire? the connector cord from pad to generator did not catch fire.Was the patient on the pad when it caught on fire? yes.Were they only testing the pad and it caught on fire without the patient being on the pad? pt.Was on pad when caught fire-the surgery had started when fire erupted.Was the fire prior to the procedure? no.Were there any patient consequences? unable to determine-will need to evaluate for any post op infection.If yes, what were they and how were they addressed? do you have a photo of the pad/cord? yes.If yes, please send to productcomplaints1@its.Jnj.Com.Is the device being returned for analysis? possible-waiting to review with internal team.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 they and how were they addressed? 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 procedure that the pad had caught on fire while the patient was on the table.No patient harm.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/8/2024.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.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.

• Brand Name: MEGASOFT UNIVERSAL PLUS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 19739479
• Report Number: 1721194-2024-00069
• Device Sequence Number: 17069152
• Product Code: GEI
• UDI-Device Identifier: 10614559104842
• UDI-Public: 10614559104842
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133726
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 0847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/08/2024
• 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-1999-2023; Z-0599-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown